[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-hepatocellular-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-hepatocellular-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,45,67,100,139,160,188,213,236,257,316,342,363,445,473,498,527,549,570,591,620,642,665,685,709],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100596243","phase-1-zanzalintinib-in-second-line-and-beyond-for-the-treatment-of-advanced-liver-cancer-100596243",false,"NCT07042919","Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Liver Cancer","A Phase Ib\u002FII Study of Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* 3.1.1 Patients with confirmed diagnosed HCC who are not amendable to curative treatments.\n* 3.1.2 Patients must have documented objective radiographic progression during or after treatment with any first or second line therapy, or intolerance to any first or second line therapy, which include immunotherapy-based combination, or non-immunotherapy-based treatment, except cabozantinib.\n* 3.1.3 Patients must have a Child-Pugh class A or Child-Pugh class B (B7 or B8) score for cirrhosis mortality. Child-Pugh class B, B9 is excluded. See Appendix A for Child-Pugh Class Scores.\n* 3.1.4 Patients must have measurable disease according to RECIST v1.1. See Section 7 for the evaluation of measurable disease. See Appendix B for RECIST v1.1 criteria.\n* 3.1.5 Patients may have had up to two prior lines therapy (not including cabozantinib) in the advanced metastatic setting. Palliative radiation or locoregional therapies are not considered a line of therapy.\n* 3.1.6 Patients must be age ≥ 18 years.\n* 3.1.7 Patients must exhibit a\u002Fan ECOG Status of 0-1 Refer to Appendix C; (Karnofsky ≥ 60%. See Appendix D.)\n* 3.1.8 Patients must have adequate organ and bone marrow function as defined below in Table 2 (Child-Pugh Class A): Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL, Hemoglobin (Hgb) ≥ 9 g\u002FdL, Platelets (PLT) ≥ 75,000\u002FmcL, International Normalized Ratio (INR) ≤ 1.7 x upper limit of normal (ULN), activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN), Total bilirubin ≤ 3.0 mg\u002Fdl, Albumin ≥ 2.5 (g\u002FdL), AST (SGOT) ≤ 5 x institutional ULN, ALT (SGPT) ≤ 5 x institutional ULN, ALP ≤ 5.0 x institutional ULN, Creatinine Clearance \\> 40 mL\u002F minute if serum creatinine is elevated above 1.5 X ULN, Urine protein-to-creatinine ratio (UPCR) ≤ 1.5 mg\u002Fmg (≤ 169.8 mg\u002Fmmol) creatinine.\n* 3.1.8 Patients must have adequate organ and bone marrow function as defined below in Table 2 (Child-Pugh Class B): Absolute neutrophil count (ANC) ≥ 1,200\u002FmcL, Hemoglobin (Hgb) ≥ 8.5 g\u002FdL, Platelets (PLT) ≥ 60,000\u002FmcL, International Normalized Ratio (INR) ≤ 2.3 x upper limit of normal (ULN), activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN), Total bilirubin ≤ 3.0 mg\u002Fdl, Albumin ≥ 2.5 (g\u002FdL), AST (SGOT) ≤ 5 x institutional ULN, ALT (SGPT) ≤ 5 x institutional ULN, ALP ≤ 5.0 x institutional ULN, Creatinine Clearance \\> 40 mL\u002F minute if serum creatinine is elevated above 1.5 X ULN, Urine protein-to-creatinine ratio (UPCR) ≤ 1.5 mg\u002Fmg (≤ 169.8 mg\u002Fmmol) creatinine.\n* 3.1.9 POCBP and any of their partners with sperm-producing reproductive capability must agree to use a highly effective method of contraception (defined in Appendix E) throughout the course of the study and for 186 days after the last dose of treatment. Additional contraceptive method, such as a barrier method (e.g., condom) is also required.\n* 3.1.10 Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence), refer to Appendix E, with partners of childbearing potential from time of informed consent, for the duration of study participation, and for 96 days following completion of therapy.\n* 3.1.11 POCBP must agree to use a highly effective method of contraception (defined in Appendix E) throughout the course of the study and for 186 days after the last dose of treatment. Additional contraceptive method, such as a barrier method (e.g., condom) is also required.\n* 3.1.12 Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements.\n* 3.1.13 Patients must have the ability to swallow, retain, and absorb oral medications or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.\n\nExclusion Criteria:\n\n* 3.2.1 Patients with prior treatment with zanzalintinib.\n* 3.2.2 Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study Day 1 treatment.\n* 3.2.3 Patients who have received ≥ 3 prior therapies in the advanced setting.\n* 3.2.4 Patients with prior Cabozantinib use.\n* 3.2.5 Patients who have had chemotherapy, cytotoxic, biologic, radiation, or other systemic anticancer (including investigational) therapy within 4 weeks prior to study Day 1 treatment.\n* 3.2.6 Patients who have received palliative radiation therapy for bone metastasis within 14 days or any other radiation therapy within 4 weeks days before first dose of study treatment.\n* 3.2.7 Patients who have undergone systemic treatment with radionuclides within 6 weeks (42 days) before first dose of study treatment.\n* 3.2.8 Patients who have received any local anticancer therapy including surgery, PEI, RFA, MWA, transarterial chemoembolization (TACE), or trans arterial radioembolization (TARE) within 28 days prior to first dose of study treatment.\n* 3.2.9 Patients with any unresolved toxicity NCI Common Terminology Criteria for Adverse Event (CTCAE 5.0) Grade \\>1 at baseline, including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy (eg, physiological replacement of corticosteroid, from a previous anticancer therapy, with the following exceptions: Alopecia, vitiligo, and the laboratory values defined in the inclusion criteria., Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the treating physician., Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with zanzalintinib may be included only after consultation with the principal investigator.\n* 3.2.10 Patients with a known prior or concurrent malignancy that is progressing or requires active treatment within 2 years of first dose of study treatment. Note: The following exceptions may be made: 1)For patients with malignancies like basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; or superficial skin cancers, localized low-grade tumors deemed cured and not treated with systemic therapy, and incidentally diagnosed prostate cancer if assessed as stage\n* 3.2.11 Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 28 days prior to first dose of study treatment. Note: Patients with an incidental finding of an isolated brain lesion \\\u003C 1 cm in diameter may be eligible after Principal Investigator approval if the lesion is radiographically stable for 28 days before first dose and does not require treatment per Investigator judgement. Note: Eligible patients must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed\n* 3.2.12 Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to zanzalintinib.\n* 3.2.13 Patients who are on concomitant anticoagulation therapy with oral anticoagulants (e.g., warfarin or direct thrombin inhibitors) and platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following: a. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH). b. Therapeutic doses of LMWH or anticoagulation with direct Factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in patients without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen. Note: Patients must have discontinued oral anticoagulants within 3 days or 5 halflives prior to first dose of study treatment, whichever is longer.\n* 3.2.14 Patients who are taking any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study with in 2 weeks prior to cycle 1 day 1. Note: Taking complementary medications to treat symptoms of the cancer is allowed.\n* 3.2.15 Patient has uncontrolled, significant intercurrent or recent illness.\n* 3.2.16 Patients with clinically significant hematuria, hematemesis, or hemoptysis of \\>0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 84 days prior to registration.\n* 3.2.17 Patients with symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n* 3.2.18 Patients with lesions invading major blood vessel including but not limited to inferior vena cava, pulmonary artery, or aorta. Note: Patients with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior vena cava) may be eligible following PI approval. Patients with lesions invading the hepatic portal vasculature are eligible\n* 3.2.19 Patients with other clinically significant disorders that would preclude safe study participation\n* 3.2.20 Patients with Recent surgery within the following parameters: • Major surgery (e.g., GI surgery or removal\u002Fbiopsy of brain metastasis) within 8 weeks before first dose of study treatment. • Prior laparoscopic surgeries (i.e. nephrectomy) within 28 days prior to first dose of study treatment. Minor surgery (e.g., simple excision, tooth extraction) within 5 days before first dose of study treatment. • Complete wound healing from major surgery and from minor surgery (e.g., simple excision, tooth extraction) must have occurred at least prior to first dose of study treatment. • Patients with clinically relevant ongoing complications from prior surgery are not eligible. • Minor surgery (e.g., simple excision, tooth extraction) within 5 days prior to first dose of study treatment. Note: if a patient has had a recent surgery outside of the proscribed interval, complete wound healing from said surgery must have occurred prior to first dose of study treatment. Note: Fresh tumor biopsies should be performed at least 5 days prior to registration. Patients with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n* 3.2.21 Patients with corrected QT interval calculated by the Fridericia formula (QTcF) \\>480 ms within 14 days per electrocardiogram (ECG) prior to first dose of study treatment. Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n* 3.2.22 Patients who are pregnant (positive serum or urine test within 72 hours prior to enrollment) or nursing. Pregnant people are excluded from this study because zanzalintinib is a next-generation TKI with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the nursing parent with zanzalintinib , breastfeeding should be discontinued if the nursing parent is treated with zanzalintinib. POCBP are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, POCBP \\\u003C 55 years-of-age must have a serum follicle stimulating hormone \\[FSH\\] level \\> 40 mIU\u002FmL to confirm menopause). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. Note: If a urine pregnancy test is positive or cannot be confirmed negative, a serum pregnancy test will be required.\n* 3.2.23 Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or give informed consent, per the opinion of the treating investigator.\n* 3.2.24 Patients with other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* 3.2.25 Patients with documented hepatic encephalopathy (HE) within 6 weeks before first dose of study treatment. Patients with clinically meaningful ascites (i.e., ascites requiring paracentesis or escalation in diuretics) within 2 weeks prior to registration, C1D1.","ALL","18 Years",{"count":20,"type":21},59,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This phase Ib\u002FII trial tests the safety, side effects, and best dose of zanzalintinib and how well it works in treating patients with hepatocellular (liver) cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Zanzalintinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Giving zanzalintinib may be safe, tolerable, and\u002For effective in treating patients with advanced liver cancer.",[28,29,30,31],"Advanced Hepatocellular Carcinoma","Cirrhosis","Stage III Hepatocellular Carcinoma AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-25","ACTUAL",{"date":38,"type":36},"2026-03-30",{"date":40,"type":21},"2031-03-04",{"name":42,"class":43},"Devalingam Mahalingam","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100605737","phase-3-testing-immunotherapy-with-or-without-stereotactic-body-radiation-therapy-in-patients-with-advanced-liver-cancer-helio-rt-trial-100605737","NCT07166406","Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial","Phase III Randomized Trial of IO-Based Systemic Treatment +\u002F- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* Diagnosis of hepatocellular carcinoma (HCC) by at least 1 criterion listed below:\n\n  * Pathologically (histologically or cytologically) proven diagnosis of HCC (strongly recommended)\n  * Radiographically proven (American Association for the Study of Liver Diseases \\[AASLD\\] criteria) diagnosis of HCC by multiphasic MRI and\u002For CT scan is allowed.\n  * For patients with a prior or concurrent malignancy, pathologic confirmation of hepatocellular cancer is required.\n* HCC macrovascular invasion, defined as enhancing vascular thrombosis demonstrating arterial enhancement and venous or delayed venous washout on multiphasic MRI and\u002For CT is required.\n* Presence of extrahepatic metastatic disease on CT chest and CT or MRI pelvis, or PET\u002FCT chest\u002Fabdomen\u002Fpelvis is permitted.\n* 5 or fewer discrete intrahepatic parenchymal foci of HCC.\n* Total maximal sum of hepatocellular carcinoma tumors, as a single conglomerate, multiple lesions, or infiltrative HCC \\\u003C 20 cm in total summed diameter.\n* No direct primary tumor extension into the stomach, duodenum, small bowel, or large bowel.\n* No known fibrolamellar HCC, sarcomatoid HCC, or biphenotypic HCC.\n* Child-Pugh class A or B7 liver function.\n* Age ≥ 18.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Not pregnant and not nursing\n\n  * Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3.\n* Platelets ≥ 60,000 cells\u002Fmm\\^3.\n* Hemoglobin ≥ 8g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] ≥ 8g\u002Fdl is acceptable).\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 6 x institutional upper limit of normal (ULN).\n* Total bilirubin \\\u003C 4 x institutional ULN.\n* Creatinine clearance (CrCL) ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 by the Cockcroft-Gault formula.\n* For treatment of HCC:\n\n  * Prior surgical resection, transarterial chemoembolization (TACE), and ablation are permitted.\n  * No prior systemic therapy or transarterial radioembolization (TARE) for HCC.\n  * No history of liver transplantation.\n* For prior treatment for any malignancy:\n\n  * Prior systemic therapy for a different cancer is allowable, except for prior immunotherapy.\n  * No prior radiotherapy to the region of the study cancer that would result in significant overlap of radiation therapy fields that would lead to excessive cumulative toxicity at the discretion of the investigator.\n* No medical contraindication to the standard of care immunotherapy.\n* For patients to be treated with atezolizumab\u002Fbevacizumab:\n\n  * No history of a gastrointestinal (GI) bleed or other clinically significant bleeding event within 6 months prior to study registration.\n* Systemic immunostimulatory agents (including, but not limited to, interferons and interleukin-2 \\[IL-2\\]) are prohibited within 4 weeks or five drug elimination half-lives (whichever is longer) prior to registration and during the study period.\n* No history of allergic reaction to the systemic therapy agent(s), compounds of similar chemical or biologic composition to the systemic therapy agent(s) (or any of its excipients).\n* PRIOR TO STEP 2 RANDOMIZATION:\n* Obtain confirmation of payment coverage (insurance or other) for both possible treatment arms.",{"count":53,"type":21},226,[55],"PHASE3","This phase III trial compares the effect of immunotherapy (IO) with stereotactic body radiation therapy (SBRT) to IO alone in treating patients with liver cancer (hepatocellular cancer) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). The usual approach is treatment with IO-based drug combinations, such as atezolizumab and bevacizumab, durvalumab and tremelimumab, or ipilimumab and nivolumab. IO with monoclonal antibodies, such as durvalumab, tremelimumab, atezolizumab, nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving IO with SBRT may be more effective than IO alone in helping patients with advanced hepatocellular cancer live longer.",[28,30,31],"2026-06-22",{"date":35,"type":36},{"date":61,"type":36},"2026-02-26",{"date":63,"type":21},"2029-03-10",{"name":65,"class":43},"NRG Oncology",139,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100562219","phase-1-a-study-to-evaluate-aln-bcat-in-patients-with-hepatocellular-carcinoma-100562219","NCT06600321","A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma","A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Has HCC confirmed histologically or cytologically, or, for patients with liver cirrhosis, clinically by the American Association for the Study of Liver Diseases (AASLD) criteria\n* Has had at least one line of systemic therapy for unresectable advanced or metastatic disease\n* Has at least one wingless-related integration site (WNT)-pathway activating mutation\n* Child-Pugh class A or B7\n\nExclusion Criteria:\n\n* Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors\n* Has symptomatic extrahepatic disease\n* Has received anti-cancer therapy or investigational drugs ≤3 weeks prior to the first dose of study drug\n\nNote: other protocol defined inclusion \u002F exclusion criteria apply",{"count":75,"type":21},158,[24],"The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.",[28,79],"Metastatic Hepatocellular Carcinoma",[81,82,83,84,85,86,87,88],"Hepatocellular carcinoma (HCC)","Pembrolizumab","CTNNB1","Liver disease","Liver cancer","Liver neoplasms","Carcinoma, hepatocellular","WNT pathway activating","2026-06-16",{"date":91,"type":36},"2026-06-17",{"date":93,"type":36},"2024-12-30",{"date":95,"type":21},"2027-10-31",{"name":97,"class":98},"Alnylam Pharmaceuticals","INDUSTRY",23,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":44},"100624088","phase-4-morning-versus-afternoon-administration-of-immunotherapy-for-the-treatment-of-advanced-or-metastatic-solid-tumors-the-knight-shift-study-100624088","NCT07405086","Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study","Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic Study","Inclusion Criteria:\n\n* Must provide written informed consent before any study-specific procedures or interventions are performed\n* Aged ≥ 18 years\n* Histologically confirmed advanced\u002Fmetastatic solid tumor as follows:\n\n  * Non small cell lung cancer (NSCLC) (driver-negative, immune checkpoint inhibitor \\[ICI\\]-eligible)\n  * Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (platinum-eligible),\n  * Renal cell carcinoma (RCC)\n  * Biliary-tract cancer (BTC)\n  * Hepatocellular carcinoma (HCC)\n  * Melanoma\n* Planned to receive a Food and Drug Administration (FDA)-approved immune check point inhibitor (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) regimen for the treatment of their malignancy\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n\nExclusion Criteria:\n\n* Prior ICI-based regimen for treatment of cancer\n* Current or prior use of immunosuppressive medication within 28 days before planned standard-of-care immunotherapy infusion, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses not exceeding 10 mg\u002Fday of prednisone (or equivalent corticosteroid)\n* Uncontrolled autoimmune disease requiring immunosuppression\n* Active, uncontrolled central nervous system (CNS) metastases",{"count":108,"type":21},160,[110],"PHASE4","This phase IV trial is evaluating whether morning versus afternoon administration of standard of care immunotherapy impacts its effectiveness in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Circadian rhythm refers to the internal biological clock in which various processes in the body, including immune cell activity, are controlled by the time of day. Exactly how this works is not fully understood, and the researchers want to see if circadian rhythm control of the immune system can influence response to immunotherapy based on whether it is given in the morning (before 11:00 am) or afternoon (12:00pm). The time of day that immunotherapy is given (morning versus afternoon) may impact the effectiveness in treating patients with advanced or metastatic solid tumors.",[113,114,28,115,116,117,118,119,120,79,121,122,123,124,125,30,126,127,31,128,129],"Advanced Biliary Tract Carcinoma","Advanced Head and Neck Squamous Cell Carcinoma","Advanced Lung Non-Small Cell Carcinoma","Advanced Malignant Solid Neoplasm","Advanced Melanoma","Advanced Renal Cell Carcinoma","Metastatic Biliary Tract Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Renal Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Stage III Lung Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","2026-06-10",{"date":132,"type":36},"2026-06-12",{"date":134,"type":36},"2026-06-08",{"date":136,"type":21},"2028-12-31",{"name":138,"class":43},"OHSU Knight Cancer Institute",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":44},"100591927","phase-2-a-study-of-bl-b01d1-monotherapy-bl-b01d1-in-combination-with-lenvatinib-bl-b01d1-in-combination-with-pd-1-monoclonal-antibody-and-bl-b01d1-in-combination-with-pd-1-monoclonal-antibody-and-bevacizumab-in-patients-with-advanced-hepatocellular-carcinoma-100591927","NCT06986785","A Study of BL-B01D1 Monotherapy, BL-B01D1 in Combination With Lenvatinib, BL-B01D1 in Combination With PD-1 Monoclonal Antibody, and BL-B01D1 in Combination With PD-1 Monoclonal Antibody and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma","A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, BL-B01D1 in Combination With Lenvatinib, BL-B01D1 in Combination With PD-1 Monoclonal Antibody, and BL-B01D1 in Combination With PD-1 Monoclonal Antibody and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Gender is not limited;\n3. Age ≥18 years old and ≤75 years old;\n4. Expected survival time ≥3 months;\n5. Patients with advanced HCC confirmed by histology or cytology;\n6. Consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions;\n7. At least one measurable lesion meeting the RECIST v1.1 definition was required;\n8. ECOG score was 0-1;\n9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. Organ function level must meet the requirements;\n12. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n13. Urinary protein ≤2+ or ≤1000mg\u002F24h;\n14. No cirrhosis or only Child-Pugh A cirrhosis;\n15. If hepatitis B virus infection is negative or positive, the status of HBV surface antigen (HBsAg) should be confirmed by HBV serological test;\n16. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Patients with active central nervous system metastases;\n2. Who had participated in any other clinical trial within 4 weeks before the trial dose;\n3. Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug;\n4. Had undergone major surgery (investigator-defined) within 4 weeks before the first dose;\n5. Systemic corticosteroids or immunosuppressive therapy is required within 2 weeks before study dosing;\n6. Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD\u002Fpulmonary inflammation requiring steroid treatment;\n7. Serious systemic infection within 4 weeks before screening;\n8. Patients at risk for active autoimmune disease or with a history of autoimmune disease;\n9. Other malignant tumors within 5 years before the first treatment;\n10. Human immunodeficiency virus antibody positive, active tuberculosis or hepatitis C virus infection;\n11. Poorly controlled hypertension by two antihypertensive drugs with different mechanisms;\n12. Diabetic patients with poor glycemic control;\n13. Had a history of severe cardiovascular and cerebrovascular diseases;\n14. Previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation;\n15. Subjects with clinically significant bleeding or significant bleeding tendency within the previous 4 weeks were screened;\n16. Patients with massive or symptomatic effusions or poorly controlled effusions;\n17. Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries or invaded the pericardium and heart;\n18. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;\n19. Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;\n20. Patients with a history of allergy to recombinant humanized antibodies or to any excipients of the trial drug;\n21. The cumulative dose of anthracyclines \\> 360 mg\u002Fm2 in previous (new) adjuvant therapy;\n22. Pregnant or lactating women;\n23. Who have a history of psychotropic drug abuse and cannot quit or have mental disorders;\n24. Other conditions for trial participation were not considered appropriate by the investigator.","75 Years",{"count":148,"type":21},74,[25],"This study is a clinical study to explore the efficacy and safety of BL-B01D1 monotherapy, BL-B01D1 in combination with lenvatinib, BL-B01D1 in combination with PD-1 monoclonal antibody, and BL-B01D1 in combination with PD-1 monoclonal antibody and bevacizumab in patients with advanced hepatocellular carcinoma.",[28],"2026-06-07",{"date":130,"type":36},{"date":155,"type":36},"2025-06-24",{"date":157,"type":21},"2027-12",{"name":159,"class":98},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":177,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100610394","phase-1-symbiotic-gi-13-a-study-to-learn-about-study-medicine-called-pf-08634404-as-a-single-treatment-and-combination-treatment-in-adult-participants-with-a-liver-cancer-called-hepatocellular-carcinoma-that-is-too-advanced-to-be-removed-by-surgery-and-may-have-spread-to-other-parts-of-the-body-100610394","NCT07227012","Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.","AN INTERVENTIONAL OPEN-LABEL PHASE 1B\u002F2 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 AS MONOTHERAPY AND COMBINATION THERAPY IN ADULT PARTICIPANTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Locally advanced or metastatic HCC with diagnosis confirmed by histology\u002Fcytology or clinically by AASLD criteria (for patients with cirrhosis). Participants without cirrhosis require histological confirmation of diagnosis.\n* Disease that is not amenable to curative surgical and\u002For locoregional therapies, or progressive disease after surgical and\u002For locoregional therapies.\n* At least 1 measurable (as defined by RECIST 1.1 per investigator) and untreated lesion.\n* Adequate hepatic, liver, and renal function\n* No prior systemic therapy for HCC.\n* ECOG performance status 0 or 1\n* Child-Pugh Class A\n\nKey Exclusion Criteria:\n\n* Moderate or severe ascites.\n* History of hepatic encephalopathy.\n* Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.\n* Clinically significant risk of hemorrhage or fistula.\n* Participants with any history of another malignancy within 3 years.\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years.\n* Clinically significant cardiovascular disease within 6 months prior to the first dose.\n* Major surgery or severe trauma within 4 weeks prior to the first dose or planned major surgery during the study.\n* History of severe bleeding tendency or coagulation dysfunction.\n* History of severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, including bleeding event due to esophageal and\u002For gastric varices, within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections.\n* Participants with history of immunodeficiency.",{"count":168,"type":21},138,[24,25],"The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have locally advanced or metastatic HCC.\n* Is not a candidate for complete surgical or loco-regional therapies.\n* Have not received any whole-body treatment for HCC.\n\nParticipants will receive PF-08634404 either alone or in combination with ipilimumab. The medicine will be given through intravenous (IV) infusions, which means it will be administered directly into a vein. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.",[172,173,174,175,176,28,79],"Carcinoma, Hepatocellular","Hepatocellular Cancer","Hepatocellular Carcinoma","Unresectable Hepatocellular Carcinoma","Liver Neoplasms",[174,85,176],"2026-06-03",{"date":180,"type":36},"2026-06-04",{"date":182,"type":36},"2025-12-01",{"date":184,"type":21},"2028-10-17",{"name":186,"class":98},"Pfizer",35,{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100500068","phase-1-au409-for-the-treatment-of-advanced-primary-liver-cancers-or-solid-tumor-with-liver-metastatic-disease-100500068","NCT05791448","AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease","First in Human Dose Escalation Study of AU409 in Patients With Advanced Primary Liver Cancers or Advanced Solid Tumor With Liver Predominant Metastatic Disease","Inclusion Criteria:\n\n* Age \\>= 18 years old\n* Patients must have histopathologically \u002Fcytologically confirmed advanced solid tumor, which is refractory to standard therapeutic options, or for which there are no standard therapeutic options. Failure of all approved therapies that have a marginal impact on survival is not required as long as the treating physician considers that treatment on study is appropriate for the subject and documents that the subject elects to defer the approved therapies\n* During the dose-escalation portion, patients must have primary liver malignancy (including hepatocellular carcinoma or cholangiocarcinoma) OR a solid tumor with liver dominant disease; liver dominant disease is defined as the majority of the tumor burden being in the liver per investigator assessment AND no more than two extrahepatic sites of disease (site of disease refers to organ or system). During the dose expansion portion of the study, eligibility may be limited to one or more tumor types depending on findings from the dose-escalation phase; this will be clarified in an amendment\n* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Patient must have recovered from any toxic effects of previous chemotherapy, targeted therapy or radiotherapy as judged by the Investigator to =\\\u003C grade 1 (except for alopecia). Residual sensory neuropathy =\\\u003C grade 2 is allowed. Residual endocrine adverse events (such as hypothyroidism or hypoadrenalism) that are manageable with replacement therapy are allowed\n* Previous chemotherapy\u002Fradiotherapy\u002Ftargeted\u002Fimmunotherapy therapy should have been completed at least 4 weeks prior to start of AU409 administration, or five half-lives, whichever is shorter (except for palliative radiation therapy that should be completed \\>= 14 days prior to study entry)\n* Patients must have an estimated life expectancy of at least 3 months\n* Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. A male participant must agree to use highly effective contraception during the intervention period and for 60 days after the last dose of AU409 and refrain from donating sperm during this period. WOCBP are eligible to participate if they are not pregnant, not breastfeeding, and agree to follow the contraceptive guidance during the study intervention period and for at least 90 days after the last dose of AU409\n\n  * Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Patients must agree, as part of the informed consent, to undergo liver biopsy (for a subset of patients enrolled at and above dose level 4) and to provide blood for pharmacokinetics analysis\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Hemoglobin \\>= 8 g\u002FdL (prior transfusion is allowed if completed 2 weeks prior to screening and hemoglobin remains \\>= 8 g\u002FdL)\n* For patients with HCC with splenic sequestration: ANC \\>= 1000\u002Fmm\\^3\n* For patients with HCC with splenic sequestration: Platelets \\>= 70,000\n* Calculated clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2. Actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For subjects with a Body Mass Index (BMI) \\> 30 kg\u002Fm\\^2, lean body weight should be used instead\n* Total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN) (subjects with known Gilbert's hepatic function disease can have bilirubin of up to 2 X ULN)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 X ULN; or AST\u002FALT =\\\u003C 5 X ULN if patient has liver tumors\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR) =\\\u003C 1.8 times upper limit of normal (unless patient is on anticoagulation)\n\nExclusion Criteria:\n\n* Patients who have had hypersensitivity to pentamidine or any excipients of AU409\n* Treatment with other anticancer therapies (including surgery, radiation therapy, chemotherapy, anti-angiogenic therapy, targeted therapy, or radiofrequency ablation therapy, etc.) or investigational therapy within 28 days prior to study entry (except for palliative radiation therapy that should be completed \\>= 14 days prior to study entry)\n* Hepatocellular carcinoma patients with a Child Pugh score \\>= B7\n* Patients with known central nervous system metastases which are untreated or symptomatic; patients with treated brain metastases (completed \\>= 30 days prior to screening) are allowed provided they are asymptomatic and are off steroids\n* Patient with a history of the following within 6 months prior to cycle 1 day 1: a myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia, cerebrovascular accident, transient ischemic attack, or seizure disorder. Atrial fibrillation is allowed if rate is controlled\n* Patients who have corrected QT (QTc) interval to \\> 470 msec (Fredericia's equation) on 2 out of 3 electrocardiogram (ECG)'s (if first ECG has QTc \\\u003C 470, no need to repeat, if first ECG has QTc \\> 470 repeat twice for a total of 3 ECG's)\n* Patients who are on therapeutic anticoagulation with warfarin; however, patients on therapeutic doses of with low molecular weight heparins or Factor Xa inhibitors are eligible\n* Patient with history of gastrointestinal surgery or malabsorptive conditions that may change the absorption of drugs and\u002For cause rapid transit (such as total gastrectomy, small bowel resection, etc.)\n* Patients who have known active hepatitis B. Patients with chronic hepatitis B who are on anti-viral therapy and have a hepatitis B viral load of =\\\u003C 500 IU\u002FmL are allowed on the study. Patients with chronic Hepatitis C are allowed\n* Patients who have active infection requiring treatment (except hepatitis B and C as noted above) including known human immunodeficiency virus (HIV) infection\n* Patients who have concurrent conditions resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents\n* Patients who have any other condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results\n* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants\n* Patients who are on medications that are considered to be strong inducers or inhibitors of the cytochrome P450 isoenzymes should have such medications discontinued or replaced. Such medications should be avoided for one week prior to first dose of treatment and during the trial participation. If these medications are absolutely necessary for the patient and cannot be replaced, enrollment may still be considered on a case by case basis if it is in the patient's best interest and after discussion with the principal investigator (PI)",{"count":196,"type":21},36,[24],"This phase I trial tests the safety, side effects, and best dose of a new intervention, AU409, in treating patients with primary liver cancers that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or advanced solid tumors that have spread to the liver (liver metastatic disease). AU409 may stop cancer from growing and spreading. This trial may help researchers determine if AU409 is safe and effective in treating patients with liver cancers and solid tumors with liver metastatic disease.",[200,28,116,201,202,30,31],"Advanced Cholangiocarcinoma","Metastatic Malignant Neoplasm in the Liver","Refractory Malignant Solid Neoplasm","2026-05-29",{"date":205,"type":36},"2026-06-01",{"date":207,"type":36},"2023-03-29",{"date":209,"type":21},"2028-03-29",{"name":211,"class":43},"University of Southern California",2,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":235},"100578424","phase-1-testing-the-addition-of-an-anti-cancer-drug-sapanisertib-to-the-usual-chemotherapy-treatment-cabozantinib-in-metastatic-liver-cell-cancer-with-a-change-in-genes-for-the-protein--catenin-the-saphire-trial-100578424","NCT06811116","Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial","A Phase I\u002FII Trial of Sapanisertib in Combination With Cabozantinib in β-catenin-mutated Hepatocellular Carcinoma (SAPHIRE)","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed HCC, not amenable to curative treatment approach\n* For Phase 2, patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam\n* For phase 2, patients must have a β-catenin mutation, based on next generation eequencing (NGS) testing through Clinical Laboratory Improvement Amendments (CLIA)-certified commercially available standard of care assay\n* Patients must have received at least one prior line of systemic therapy in the metastatic setting, including a prior immune checkpoint inhibitor therapy unless not eligible. For the phase 2 portion, patients must have received at least one and no more than two prior lines of systemic therapy in the metastatic setting, including a prior immune checkpoint inhibitor therapy unless not eligible\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of sapanisertib in combination with cabozantinib in patients \\\u003C18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)\n* Child Pugh score of A\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 30,000\u002FmcL\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5 × institutional ULN\n* Glomerular filtration rate (eGFR) ≥ 40 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* For the phase 2 portion, availability of archival tumor tissue at the time of patient enrollment for banking for molecular profiling studies\n* The effects of sapanisertib and cabozantinib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and after completion of drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Both men and women treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for the following duration after completion of sapanisertib and cabozantinib administration:\n\n  * 90 days and 120 days after last dose of sapanisertib for women of childbearing potential and men respectively,\n  * 5 months and 7 months after last dose of cabozantinib for women of childbearing potential and men respectively\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sapanisertib and cabozantinib\n* Use of strong CYP3A4-inhibiting agents due to drug-drug interaction with cabozantinib\n* Prior exposure to cabozantinib\n* Patients who are unable to swallow oral medications such as capsules and tablets and patients with gastrointestinal conditions that may affect the absorption of oral medications\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because sapanisertib and cabozantinib have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sapanisertib and cabozantinib, breastfeeding should be discontinued if the mother is treated with sapanisertib and cabozantinib",{"count":221,"type":21},92,[24,25],"This phase I\u002FII trial studies the side effects and best dose of sapanisertib when given together with cabozantinib, and to see how well they work in treating patients with liver cancer that has spread from where it first started to other places in the body (metastatic) and contains a mutation (change) in the β-catenin gene. Sapanisertib and cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sapanisertib and cabozantinib together may work better than giving cabozantinib alone in treating β-catenin-mutated metastatic hepatocellular carcinoma.",[28,79,30,31],"2026-05-12",{"date":227,"type":36},"2026-05-13",{"date":229,"type":36},"2025-11-17",{"date":231,"type":21},"2027-08-31",{"name":233,"class":234},"National Cancer Institute (NCI)","NIH",4,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":44},"100563630","phase-3-a-clinical-study-of-shr-8068-combined-with-adebrelimab-and-bevacizumab-versus-sintilimab-or-atezolizumab-combined-with-bevacizumab-for-the-treatment-of-advanced-hepatocellular-carcinoma-100563630","NCT06618664","A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma","A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study of Anti CTLA-4 Antibody SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent.\n2. ≥ 18 years old, both male and female.\n3. Unresectable locally advanced or metastatic HCC confirmed by histopathologically\u002Fcytologically.\n4. At least one measurable lesion based on RECIST v1.1 criteria.\n5. Barcelona clinic liver cancer: Stage B or C.\n6. No previous systemic antitumor therapy for HCC.\n7. ECOG PS of 0-1.\n8. Child-Pugh score of A or B7.\n9. Expected survival period ≥ 12 weeks.\n10. Adequate organ function.\n11. Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.\n\nExclusion Criteria:\n\n1. Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.\n2. Patients with other malignancies currently or within the past 5 years.\n3. With known severe allergic reactions to any other monoclonal antibodies.\n4. Patients with known CNS metastasis or hepatic encephalopathy.\n5. Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.\n6. Patients with symptomatic ascites or pleural effusion.\n7. Patients with hypertension which cannot be well controlled by antihypertensives.\n8. Uncontrolled cardiac diseases or symptoms.\n9. Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs).\n10. Major vascular disease occurred in the 6 months before randomization.\n11. Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization.\n12. Major surgery within 28 days before randomization or expected to require major surgery during the study period.\n13. Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC \\> 15×109\u002FL at baseline.\n14. Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection.\n15. Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period\n16. Patients with other potential factors that may affect the study results.",{"count":244,"type":21},590,[55],"THis study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab or Atezolizumab combined with Bevacizumab for the first-line treatment of advanced HCC.",[28],"2026-04-28",{"date":250,"type":36},"2026-05-04",{"date":252,"type":36},"2024-10-28",{"date":254,"type":21},"2030-12",{"name":256,"class":98},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":212},"100513775","phase-2-at-home-cancer-directed-therapy-versus-in-clinic-for-the-treatment-of-patients-with-advanced-cancer-100513775","NCT05969860","At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer","Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic","Inclusion Criteria:\n\n* Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required.\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines.\n\n  * Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens:\n  * Eligible disease cancer types:\n\n    * Anal cancer\n    * Appendiceal carcinoma\n    * Basal cell carcinoma\n    * Bladder cancer\n    * Biliary cancer\n    * Breast cancer\n    * Central Nervous System malignancy including glioblastoma\n    * Cervical cancer\n    * Cholangiocarcinoma\n    * Colorectal carcinoma\n    * Endometrial cancer\n    * Fallopian tube cancer\n    * Gastroesophageal cancer \\[including gastric, esophageal, and gastroesophageal junction (GEJ) cancers\\]\n    * Germ cell carcinoma\n    * Head and Neck cancer\n    * Hepatocellular Carcinoma\n    * Liver\n    * Lung\n    * Lymphoma\n    * Melanoma\n    * Merkel Cell\n    * Multiple Myeloma\n    * Myelodysplastic syndrome\n    * Myeloid Disorders\n    * Neuroendocrine carcinoma\n    * Ovarian cancer\n    * Pancreatic adenocarcinoma\n    * Penile carcinoma\n    * Peritoneal carcinoma\n    * Prostate cancer\n    * Renal cell cancer\n    * Sarcoma\n    * Squamous cell Carcinoma of the Skin\n    * Testicular cancer\n    * Urethral carcinoma\n    * Vaginal carcinoma\n    * Vulvar carcinoma\n  * Eligible Regimens\n\n    * Fluorouracil (5-FU) +\u002F- leucovorin +\u002F- bevacizumab +\u002F- trastuzumab\n    * 5FU +\u002F- leucovorin +\u002F- bevacizumab +\u002F- nivolumab\n    * Atezolizumab +\u002F- bevacizumab\n    * Atezolizumab +\u002F- bevacizumab + cobimetinib, atezolizumab +\u002F- bevacizumab + vemurafenib, atezolizumab +\u002F- bevacizumab + cobimetinib + vemurafenib\n    * Avelumab\n    * Avelumab + axitinib\n    * Bevacizumab\n    * Bevacizumab + capecitabine\n    * Bevacizumab + irinotecan (+\u002F- capecitabine)\n    * Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib\n    * Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus\n    * Bevacizumab + trifluridine\u002Ftipiracil\n    * Bortezomib\n    * Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor\n    * Bortezomib + venetoclax\n    * Carfilzomib\n    * Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor\n    * Carfilzomib + venetoclax\n    * Cemiplimab\n    * Cisplatin\n    * Cisplatin\u002F5-FU\n    * Cisplatin\u002Fetoposide\n    * Cisplatin + durvalumab\n    * Cisplatin + gemcitabine\n    * Cisplatin + gemcitabine + durvalumab\n    * Daratumumab (+ oral \\[PO\\] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Degarelix\n    * Durvalumab\n    * Durvalumab + tremelimumab\n    * Eribulin\n    * FOLFIRI +\u002F- bevacizumab (5FU +\u002F- leucovorin + irinotecan)\n    * Fam-trastuzumab deruxtecan\n    * Fulvestrant\n    * Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib\n    * Gemcitabine\n    * Gemcitabine + durvalumab\n    * Gemcitabine + paclitaxel protein-bound\n    * Goserelin acetate\n    * Irinotecan\n    * Irinotecan + capecitabine\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + cabozantinib\n    * Nivolumab-relatlimab\n    * Octreotide\n    * Paclitaxel\n    * Pembrolizumab\n    * Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +\u002F- trametinib, pembrolizumab + trametinib)\n    * Pemetrexed\n    * Pertuzumab\n    * Pemetrexed + pembrolizumab\n    * Rituximab\n    * Trastuzumab + paclitaxel\n    * Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+\u002F- tucatinib +\u002F- capecitabine)\n    * Decitabine\n    * These regimens can be used only if patients are receiving one of the regimens above:\n\n      * Darbepoetin-alfa\n      * Epoetin\n      * Filgrastim\n* Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as:\n\n  * Zoledronic acid\n  * Denosumab\n* Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent\n* Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.\n* Residing within the area serviced by supplier and paramedic network\n* Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution\n* Age \\>= 18 years at time of registration\n* Signed informed consent form by patient\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Ability to complete questionnaire(s) by themselves or with assistance\n* RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate tolerability to the standard of care cancer therapy and no drug-related infusion reactions since pre-registration and prior to registration\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant standard of care oral drugs such as ribociclib, abemaciclib, or palbociclib in combination with endocrine therapy (e.g., Leuprolide, fulvestrant intramuscular \\[IM\\], etc.); tucatinib and capecitabine in combination with trastuzumab and pertuzumab for HER2 positive breast cancer; dexamethasone, cyclophosphamide, lenalidomide or pomalidomide for multiple myeloma; temozolomide, lomustine, or afinitor in combination with avastin for glioblastoma. In addition, all oral anti-hormonal agents for breast and prostate cancer are permitted (e.g., tamoxifen, arimidex, abiraterone, etc.) if used in combination with any of the drugs\n* Requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction =\\\u003C 6 months\n  * Wound healing disorder\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":265,"type":21},220,[25],"This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.",[269,113,270,271,272,273,274,275,276,277,278,279,280,281,116,282,283,284,285,286,287,288,289,290,200,291,292,293,28,294,295,296,117,297,298,299,118,300,301,302,303,304,305,306],"Advanced Anal Carcinoma","Advanced Bladder Carcinoma","Advanced Breast Carcinoma","Advanced Carcinoid Tumor","Advanced Cervical Carcinoma","Advanced Colorectal Carcinoma","Advanced Gastric Carcinoma","Advanced Glioblastoma","Advanced Head and Neck Carcinoma","Advanced HER2 Positive Breast Carcinoma","Advanced Lung Carcinoma","Advanced Lung Small Cell Carcinoma","Advanced Malignant Germ Cell Tumor","Advanced Neuroendocrine Carcinoma","Advanced Ovarian Carcinoma","Advanced Pancreatic Carcinoma","Advanced Prostate Small Cell Neuroendocrine Carcinoma","Advanced Prostate Carcinoma","Hematopoietic and Lymphoid System Neoplasm","Multiple Myeloma","Myelodysplastic Syndrome","Advanced Basal Cell Carcinoma","Advanced Endometrial Carcinoma","Advanced Esophageal Carcinoma","Advanced Fallopian Tube Carcinoma","Advanced Liver Carcinoma","Advanced Lymphoma","Advanced Malignant Testicular Neoplasm","Advanced Merkel Cell Carcinoma","Advanced Penile Carcinoma","Advanced Primary Malignant Central Nervous System Neoplasm","Advanced Sarcoma","Advanced Skin Squamous Cell Carcinoma","Advanced Urethral Carcinoma","Advanced Vaginal Carcinoma","Advanced Vulvar Carcinoma","Advanced Appendix Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","2026-04-15",{"date":309,"type":36},"2026-04-20",{"date":311,"type":36},"2023-08-23",{"date":313,"type":21},"2027-01-01",{"name":315,"class":43},"Mayo Clinic",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":326,"conditions":327,"keywords":330,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":44},"100576788","phase-2-ligufalimab-and-cadonilimab-in-advanced-liver-cancers-100576788","NCT06789848","Ligufalimab and Cadonilimab in Advanced Liver Cancers","Phase II Basket Trial of Ligufalimab (AK117) and Cadonilimab (AK104) in Advanced Hepatobiliary Cancers","Inclusion Criteria:\n\n1. Histological confirmation of specific disease -Cohort A (HCC): Patient must have a diagnosis confirmed by histology or clinically by the American Association for the Study of Liver Diseases (AASLD) criteria in patients with cirrhosis. Known fibrolamellar HCC will be excluded.\n\n   * Cohort B (BTC, biliary tract cancers): Patients must have histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers). Patients with combined HCC-cholangiocarcinoma may be enrolled in Cohort B.\n2. Locally advanced or metastatic disease\n\n   * Patients with locally advanced or metastatic disease must have disease deemed not amenable to surgical and\u002For locoregional therapies or patients who have progressed following surgical and\u002For locoregional therapies.\n   * Measurable disease, as defined as lesions that can accurately be measured in at least one dimension according to RECIST version 1.1 at least 1 cm with contrast enhanced dynamic imaging (magnetic resonance imaging or computed tomography).\n3. Refractory to or relapsed after prior anti-PD-1\u002FL1 antibody therapy. May have received anti-PD-1\u002FL1 monotherapy or combination therapy as any line of therapy including in the neoadjuvant or adjuvant setting. Patients who discontinued prior immune checkpoint inhibitor treatment due to a high-grade toxicity (Grade 4) are not eligible.\n4. For patients in cohort A who do not have a clinical diagnosis of HCC according to the AASLD criteria, formalin-fixed, paraffin-embedded (FFPE) tumor diagnostic tissue samples must have been obtained within 4 years from the time of consent. Baseline tissue will be requested any time after consent. It is strongly recommended that tissue is obtained from standard-of-care biopsies confirming progression of disease on prior therapy so that the patient has not received any intervening systemic anti-cancer treatment from the time that the baseline tissue was obtained.\n5. Prior locoregional therapy is allowed provided the following are met: 1) at least 2 weeks since prior locoregional therapy including surgical resection, chemoembolization, radiotherapy, or ablation; 2) target lesion has increased in size ≥25% since the cessation of locoregional therapy or the target lesion was not treated with locoregional therapy. Patients treated with palliative radiotherapy for symptoms will be eligible as long as the target lesion is not the treated lesion and radiotherapy will be completed at least 2 weeks prior to study drug administration.\n6. Age ≥ 18 years\n7. Child-Pugh Score A or B7 (only applicable for Cohort A)\n8. ECOG Performance score of 0-1\n9. Adequate organ and marrow function (without chronic, ongoing growth factor support or transfusion in the last 2 weeks) as defined below:\n\n   -Platelet count ≥ 50,000\u002Fmm3\n\n   -Hgb ≥ 9 g\u002Fdl\n\n   -Absolute neutrophil ≥ 1,000 cells\u002Fmm3\n\n   -Total bilirubin ≤ 3 mg\u002Fml (This will not apply to subjects with Gilbert's syndrome who have persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis, or patients with hyperbilirubinemia secondary to distal malignant obstruction where endoscopic, surgical, or percutaneous bypass\u002Fstenting has been attempted. Such patients may be enrolled based in consultation with the principal investigator)\n\n   -INR ≤ 2\n\n   -AST, ALT ≤ 5 times ULN\n   * Calculated creatinine clearance (CrCl) ≥ 40 mL\u002Fmin. CrCl can be calculated using the Cockroft-Gault method.\n   * Albumin ≥ 2.0 g\u002Fdl\n10. All men, as well as women of child-bearing potential, defined as not surgically sterilized and between menarche and 1-year post menopause, must agree to use highly effective contraception methods (hormonal or barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation, and for 120 days after the last dose of ligufalimab or cadonilimab.\n\nShould a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nA female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\n  11\\. Women of child-bearing potential must have a negative serum pregnancy test at screening.\n\n  12\\. Subjects are eligible to enroll if they have non-viral-HCC, or if they have HBV-HCC, or HCV-HCC defined as follows:\n\n  1\\) HBV-HCC: Hepatitis B subjects will be allowed if they meet the following criteria: On antiviral therapy for HBV. Subjects who are anti-HBc (+), negative for HBsAg, negative for anti-HBs, and have an HBV viral load under 100 IU\u002FmL do not require HBV anti-viral prophylaxis.\n\n  2\\) HCV-HCC: Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody. Patients who have failed HCV therapy as evidenced by detectable HCV RNA will be eligible. Subjects with chronic infection by HCV who are treated (successfully or treatment failure) or untreated are allowed on study.\n\n  13\\. Ability to understand and the willingness to sign a written informed consent.\n\n  14\\. Willing and able to comply with the requirements and restrictions in this protocol.\n\n  15\\. Patients who have received the vector, protein subunit, or nucleic acid COVID-19 vaccines are eligible to enroll.\n\nExclusion Criteria:\n\n1. Prior liver transplant.\n2. Known human immunodeficiency virus (HIV) positive (testing not required).\n3. Use of any live vaccines against infectious diseases within 28 days of first dose of study drug administration.\n4. History of trauma or major surgery within 28 days prior to the first dose of study drug administration. (Tumor biopsy or placement of central venous access catheter (eg, port or similar) is not considered a major surgical procedure).\n5. Underlying medical conditions that, in the investigator's opinion, will make the administration of study drugs hazardous, including but not limited to:\n\n   * Interstitial lung disease, including history of interstitial lung disease or non infectious pneumonitis (lymphangitic spread of cancer is not disqualifying),\n   * Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of study drugs,\n   * Clinically significant cardiovascular disease,\n   * A condition that may obscure the interpretation of toxicity determination or AEs,\n   * History of prior solid-organ transplantation.\n6. Hypersensitivity to IV contrast; not suitable for pre-medication.\n7. Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma\u002Fatopy.\n\n   * Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n   * Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study. Participants on chronic systemic corticosteroids will be excluded from the study.\n8. Known history of active bacillus tuberculosis.\n9. Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) or other immunosuppressive medications within 14 days of study administration. Inhaled or topical steroids and adrenal replacement doses ≤10 mg\u002Fday prednisone equivalents are permitted in the absence of autoimmune disease.\n10. Patients who discontinued prior immune checkpoint inhibitor treatment due to Grade ≥ 3 or Grade 2 serious toxicity (i.e., pneumonitis, uveitis, neurological symptoms, cardiac toxicity, etc.) immune-related adverse events.\n11. Known severe hypersensitivity reactions to monoclonal antibodies (≥Grade 3).\n12. Prior malignancy that required systemic treatment within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer.\n13. Prisoners or subjects who are involuntarily incarcerated.\n14. If a participant has symptomatic or clinically active brain metastases including leptomeningeal disease, they must be excluded if:\n\n    * Has evidence of progression by neurologic symptoms\n    * Has metastatic brain lesions that require immediate intervention.\n    * Has carcinomatous meningitis, regardless of clinical stability\n15. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation, confirmed by a positive hCG laboratory test.\n16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n17. Has significant dementia or other mental condition that precludes the participant's ability to consent to the study.\n18. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drugs.\n19. Known hypersensitivity to recombinant proteins, or any excipient contained in the study drug formulations.",{"count":324,"type":21},64,[25],"The goal of this clinical trial is to find out if the combination of Ligufalimab and Cadonilimab are effective in treating advanced hepatobiliary cancers that have failed prior therapy.",[28,328,329],"Refractory Hepatocellular Carcinoma","Biliary Tract Cancer",[331,332],"liver","other digestive organs","2026-02-25",{"date":335,"type":36},"2026-02-27",{"date":337,"type":36},"2025-02-18",{"date":339,"type":21},"2030-05-31",{"name":341,"class":43},"University of Texas Southwestern Medical Center",{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":235},"100606362","phase-2-celecoxib-durvalumab-and-tremelimumab-for-the-treatment-of-patients-with-advanced-or-metastatic-liver-cancer-100606362","NCT07174570","Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer","Repurposing Celecoxib to Overcome Resistance to Immunotherapy in Advanced HCC (RECON Study)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed hepatocellular cancer (HCC) planned for treatment at gastrointestinal clinics of Emory University's Winship Cancer Institute or Grady Cancer Center\n* Radiologically measurable disease based on Response Evaluation Criteria in Solid Tumors version (RECIST) 1.1\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Platelet count \\> 100,000 cells\u002F ul (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Hemoglobin (Hb) \\> 9g\u002Fdl (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Absolute neutrophil count \\> 1000 cells\u002Fdl (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Albumin \\> 3g\u002Fdl (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Total bilirubin \\\u003C 3mg\u002Fdl (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Glomerular filtration rate (GFR) \\> 60ml\u002Fmin (based on creatine, and cystatin C estimation where applicable) (within 28 days of cycle 1 day 1, at the discretion of the investigator)\n* Females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy\n* FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 3 months after completion of study drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n  \\* A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Completion of all previous cancer directed therapy (including, radiotherapy, liver lesion ablation, bland or chemoembolization and transarterial radioembolization therapy) ≥ 4 weeks before the start of study therapy.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class IIB or better.\n\n  * Patients without existing cardiac disease that could raise the risk of complications who consent for the trial will proceed with trial participation\n  * Patients with existing cardiac disease that could raise the risk of complications will be referred at the discretion of the investigator to a cardio-oncologist or general cardiologist for cardiac optimization prior to starting celecoxib\n* Life expectancy \\> 12 weeks as determined by the investigator\n* Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions. This includes willingness to undergo mandatory blood sample draws for evaluation of correlatives\n* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n* Mild to moderate liver dysfunction evidenced by Child Pugh score 7B and above\n* History of arterial or venous thromboembolic events or gastrointestinal bleeding event. Subjects with portal venous thrombosis are permitted in the study if their treating oncologist does not deem it necessary to treat this with heparin products or direct acting anticoagulant (DOAC)\n* Current use of warfarin, heparin products and DOACs\n* Subjects with a history of (non-bleeding) peptic ulcer disease who have been on a proton pump inhibitor for less than 30 days prior to screening visit\n* Patients who have had immune checkpoint inhibitors (ICI) therapy within 6 months prior to entering the study or those who have not recovered from adverse events due to liver directed therapy administered more than 4 weeks earlier (i.e., have residual toxicities \\> grade 2)\n* Patients who are receiving any other investigational agents or an investigational device within 28 days before administration of first dose of study drugs\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study\n* Contraindication to ICI per investigator discretion\n* Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled grade ≥ 3 hypertension (diastolic blood pressure ≥ 100 mmHg or systolic blood pressure ≥ 160 mmHg) despite antihypertensive therapy\n* Contraindication to non-steroidal anti-inflammatory drugs (NSAIDs): cardiac conditions that significantly raise the risk of cardiopulmonary complications, including unstable angina, uncontrolled heart failure, recent gastrointestinal (GI) bleed. Note that patients who are stable on low dose aspirin (\\\u003C 325mg\u002Fday) only will be allowed on study\n* Current use of other NSAIDs.",{"count":350,"type":21},39,[25],"This phase II trial tests how well the combination of celecoxib with durvalaumab and tremellimumab works in treating patients with hepatocellular cancer (liver cancer) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Celecoxib belongs to the family of drugs called nonsteroidal anti-inflammatory agents and is used to reduces pain. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving celecoxib with durvalaumab and tremellimumab may better treat patients with advanced or metastatic liver cancer.",[28,79,30,31],"2026-01-26",{"date":356,"type":36},"2026-01-28",{"date":358,"type":36},"2026-01-02",{"date":360,"type":21},"2027-11-13",{"name":362,"class":43},"Emory University",{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":44},"100446356","phase-1-phase-i-study-of-tumor-treating-fields-ttf-in-combination-with-cabozantinib-or-with-pembrolizumab-and-nab-paclitaxel-in-patients-with-advanced-solid-tumors-involving-the-abdomen-or-thorax-100446356","NCT05092373","Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax","Inclusion Criteria:\n\n* Participants must have pathologically confirmed advanced\u002Fmetastatic solid cancer (hepatocellular carcinoma, renal cell carcinoma, breast cancer, ovarian\u002Ffallopian, or endometrial\u002Fprimary peritoneal tumors) involving the abdomen or thorax, cannot tolerate standard therapy or have experienced tumor progression on standard therapy.\n* Age: ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Life expectancy \\>3 months.\n* Normal bone marrow function, defined as absolute neutrophil count ≥1,000\u002FµL; platelets ≥75,000\u002FµL; hemoglobin ≥8 g\u002FdL.\n* Adequate hepatic function as defined by a total bilirubin level ≤1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's syndrome, and alanine aminotransferase (ALT)\u002F serum glutamic pyruvic transaminase levels (SGPT) ≤2.5 x ULN (unless the patient has liver metastases: ALT)\u002F serum glutamic pyruvic transaminase levels (SGPT) ≤5 x ULN).\n* Participants with HCC must have a Child Pugh status A, no clinically significant ascites (requiring pharmacological or interventional treatment), and no history (or increased risk) of esophageal\u002Fgastric bleeding, impaired wound healing, perforation or fistula.\n* Serum creatinine clearance ≥50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Measurable disease by RECIST or evaluable disease.\n* Contraception: Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months and who have not had a tubal ligation, hysterectomy, or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. Male participants must agree to use effective contraception or abstinence while on study.\n* Able to operate the TTF device independently or with the help of a caregiver.\n\nExclusion Criteria:\n\n* Participants must not receive prior anticancer therapy or radiation therapy within 2 weeks and must not undergo major surgery within 4 weeks prior to initiation of treatment on protocol. Participants who are already on cabozantinib and have progressive disease are allowed to transition to treatment with tumor treating fields and cabozantinib. Participants in both cohorts who already started treatments as standard of care (Cohort 1: Cabozantinib and Cohort 2: nab-paclitaxel and Pembrolizumab) are allowed to start on protocol within the first 2-3 weeks of treatment initiation. Palliative radiation therapy is allowed.\n* Participants must have recovered to Grade 0-1 toxicity from prior therapy.\n* Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by brain imaging for at least 4 weeks and the patient must have been off steroids for at least 2 weeks.\n* The patient has cardiac conditions as follows: uncontrolled: hypertension (blood pressure \\[BP\\] \\> 160\u002F100) despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure (New York Heart Association Class II or above), prior or current cardiomyopathy, uncontrolled atrial fibrillation with heart rate \\> 100 beats per minute (bpm), unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly).\n* The patient has concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).\n* Concurrent malignancies are permitted if (A) they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or (B) with agreement from the Principal Investigator (PI), participants who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or (C) with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.\n* The patient is pregnant or breastfeeding.\n* History of hypersensitivity or contraindication to TTF.\n* Implanted pacemaker, defibrillator or other electrical medical devices.\n* The participant has a previously-identified allergy or hypersensitivity to cabozantinib, nab-paclitaxel, or pembrolizumab, medical adhesives or hydrogel or the patient has received prior cabozantinib and discontinued therapy due to unacceptable toxicity.\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* The patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.\n* CABOZANTINIB COHORT ONLY: The patient has experienced clinically-significant hematemesis or hemoptysis of \\> 0.5 teaspoon of red blood, or other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment.\n* CABOZANTINIB COHORT ONLY: The patient has a cavitating pulmonary lesion(s) or a pulmonary lesion abutting or encasing a major blood vessel.\n* CABOZANTINIB COHORT ONLY: The patient has received drugs used to control loss of bone mass within 4 weeks prior to the first dose of study treatment.\n* CABOZANTINIB COHORT ONLY: The patient has prothrombin time\u002Finternational normalized ratio (PT\u002FINR) or partial thromboplastin time (PTT) test results that are above (1.3X) the laboratory upper limit of normal.\n* CABOZANTINIB COHORT ONLY: The subject has a corrected QT interval (QTcF) \\> 450 ms for men or \\> 470 ms for women.\n* CABOZANTINIB COHORT ONLY: The patient requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or Coumadin-related agents, heparin, thrombin or FXa inhibitors, and antiplatelet agents. Low-dose aspirin (≤ 81 mg\u002Fday), low dose warfarin (≤ 1mg\u002Fday), and prophylactic low molecular weight heparin (LMWH) are permitted.\n* CABOZANTINIB COHORT ONLY: Patients with encasement of a major artery or bowel by tumor are excluded.\n* CABOZANTINIB COHORT ONLY: The patient is unable to swallow capsules.\n* CABOZANTINIB COHORT ONLY: History of hypersensitivity or contraindication to cabozantinib.\n* ATEZOLIZUMAB-CONTAINING COHORT: Participants who have received prior immunotherapy, including prior anti-PD-1 or anti-PD-L1 therapies may participate: (A) only if their prior anti-PD-1 or anti-PDL1 monotherapy or combination therapy were NOT the last treatment prior to participation on this study. (B) Participants who had prior immunotherapies and experienced Grade 1-2 immune-related adverse event (irAE) must have documentation that their irAEs are Grade 1 or 0 using current Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0) and participants must be off steroid therapy and\u002For other immunosuppressive therapy, as treatment for irAEs, for \\>= 14 days from Cycle 1, Day 1. (C) Participants who experienced Grade 3 irAEs consisting of laboratory abnormalities that were asymptomatic and have now resolved to Grade 1 or 0 and participants who have been off steroid and\u002For other immunosuppressive therapy, as treatment for irAEs, for \\>= 30 days from Cycle 1, Day 1. Participants with prior irAE pneumonitis (\\>= Grade 2) should not be given atezolizumab.\n* ATEZOLIZUMAB-CONTAINING COHORT: Human immunodeficiency virus (HIV) infection, active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics.\n* ATEZOLIZUMAB-CONTAINING COHORT: Has received a live vaccine within 30 days prior to first dose.\n* ATEZOLIZUMAB-CONTAINING COHORT: Active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.\n* ATEZOLIZUMAB-CONTAINING COHORT: Serious autoimmune disease at the discretion of the treating attending: Patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g. Wegener's Granulomatosis) are excluded from this study.\n* ATEZOLIZUMAB-CONTAINING COHORT: History of\u002For current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician.",{"count":370,"type":21},43,[24],"This phase Ib trial tests the safety, side effects, and best dose of tumor treating fields therapy in combination with either cabozantinib or nab-paclitaxel and atezolizumab in treating patients with solid tumors involving the abdomen or thorax that have spread to other parts of the body (advanced). Tumor treating fields therapy on this study utilizes NovoTTF systems that are wearable devices that use electrical fields at different frequencies that may help stop the growth of tumor cells by interrupting cancer cells' ability to divide. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tumor treating fields therapy in combination with either cabozantinib, or with nab-paclitaxel and atezolizumab may help control advanced solid tumors involving the abdomen or thorax.",[271,291,293,28,374,375,376,283,377,118,378,379,380,381,382,383,384,385,386,387,79,388,389,390,391,392,124,393,394,395,396,397,398,30,399,400,127,401,402,403,404,405,406,407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422,31,423,424,129,425,426,427,428,429,430,431,432,433,434,435],"Advanced Malignant Abdominal Neoplasm","Advanced Malignant Female Reproductive System Neoplasm","Advanced Malignant Thoracic Neoplasm","Advanced Primary Peritoneal Carcinoma","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Malignant Abdominal Neoplasm","Malignant Solid Neoplasm","Metastatic Breast Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Fallopian Tube Carcinoma","Metastatic Malignant Abdominal Neoplasm","Metastatic Malignant Female Reproductive System Neoplasm","Metastatic Malignant Thoracic Neoplasm","Metastatic Ovarian Carcinoma","Metastatic Primary Peritoneal Carcinoma","Prognostic Stage III Breast Cancer AJCC v8","Prognostic Stage IIIA Breast Cancer AJCC v8","Prognostic Stage IIIB Breast Cancer AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Prognostic Stage IV Breast Cancer AJCC v8","Stage III Fallopian Tube Cancer AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Primary Peritoneal Cancer AJCC v8","Stage III Uterine Corpus Cancer AJCC v8","Stage IIIA Fallopian Tube Cancer AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIA Ovarian Cancer AJCC v8","Stage IIIA Primary Peritoneal Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIA1 Fallopian Tube Cancer AJCC v8","Stage IIIA1 Ovarian Cancer AJCC v8","Stage IIIA2 Fallopian Tube Cancer AJCC v8","Stage IIIA2 Ovarian Cancer AJCC v8","Stage IIIB Fallopian Tube Cancer AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IIIB Ovarian Cancer AJCC v8","Stage IIIB Primary Peritoneal Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Fallopian Tube Cancer AJCC v8","Stage IIIC Ovarian Cancer AJCC v8","Stage IIIC Primary Peritoneal Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Fallopian Tube Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Primary Peritoneal Cancer AJCC v8","Stage IV Uterine Corpus Cancer AJCC v8","Stage IVA Fallopian Tube Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVA Primary Peritoneal Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Fallopian Tube Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVB Ovarian Cancer AJCC v8","Stage IVB Primary Peritoneal Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","2026-01-13",{"date":438,"type":36},"2026-01-14",{"date":440,"type":36},"2022-04-29",{"date":442,"type":21},"2026-09-01",{"name":444,"class":43},"M.D. Anderson Cancer Center",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":453,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":457,"conditions":458,"keywords":459,"overallStatus":462,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":4},"100615826","phase-2-first-line-lenvatinib-in-child-pugh-b-patients-with-hcc-unsuitable-for-curative-treatment-100615826","NCT07297654","First-Line Lenvatinib in Child-Pugh B Patients With HCC Unsuitable for Curative Treatment","First-Line Lenvatinib in Child-Pugh B Patients With HCC Unsuitable for Curative Treatment: A Phase 2 FINELAND Trial","FINELAND","Inclusion Criteria:\n\n1. Signed informed consent\n2. Age ≥ 19 years at the time of signing informed consent\n3. Histological or clinical diagnosis of HCC according to the Korean Liver Cancer Association-National Cancer Center guidelines\n4. HCC not amenable to curative treatment (e.g., surgical resection, local therapy, liver transplantation)\n5. At least one measurable target lesion according to RECIST v1.1\n\n   \\- Participants who previously received local treatment (e.g., radiofrequency ablation, microwave ablation, transarterial chemoembolization, transarterial radioembolization, transarterial embolization, or radiotherapy) are eligible if (a) target lesions have not been treated by prior local therapy, or (b) lesions within the field of local therapy have subsequently progressed according to RECIST v1.1.\n6. Child-Pugh class B7-B8\n7. ECOG performance status (PS) 0-2\n8. Adequate hematologic and end-organ function defined by the following laboratory tests obtained within 14 days prior to screening:\n\n   * Hemoglobin ≥ 8.0g\u002FdL\n   * Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3\n   * Platelet count ≥ 50,000\u002FμL\n   * Total bilirubin \\\u003C 3.5 mg\u002FdL\n   * Serum albumin ≥ 2.5 g\u002FdL\n   * ALT and AST ≤ 7 x upper limit of normal (ULN)\n   * Prothrombin time (INR ≤ 1.8 × ULN)\n   * Serum creatinine ≤ 2.0 × ULN or calculated creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault equation)\n9. Documented virological status for hepatitis B virus (HBV) and hepatitis C virus (HCV) by screening tests.\n\n   \\- Participants with HBV or HCV infection must receive antiviral therapy in accordance with institutional guidelines.\n10. Women of childbearing potential must agree to remain abstinent or use effective contraception (failure rate \\\u003C 1% per year) from signing informed consent through at least 6 months after the last study drug administration.\n\nMen must agree to remain abstinent or use effective contraception (failure rate \\\u003C 1% per year) during the same period and refrain from sperm donation.\n\nExclusion Criteria:\n\n1. Fibrolamellar carcinoma or sarcomatoid carcinoma\n2. Prior systemic therapy for HCC\n3. Local therapy for HCC (including radiofrequency ablation, microwave ablation, cryoablation, transarterial chemoembolization, radioembolization, or radiotherapy) within 28 days prior to initiation of study treatment, or unresolved complications from such procedures\n\n   \\- Palliative radiotherapy to bone lesions is permitted with a 7-day washout\n4. History of allogeneic stem cell or solid organ transplantation\n5. Active brain metastases or leptomeningeal disease\n6. History of another malignancy within 2 years prior to screening, except for cancers with negligible risk of metastasis or death (e.g., \\>90% 5-year survival)\n7. Serious uncontrolled medical comorbidities within 3 months prior to study treatment, including severe cardiovascular disease (NYHA class ≥ II heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina, or any condition judged by the investigator to increase participant risk\n8. Pregnant or breastfeeding women, or men and women of reproductive potential unwilling to use effective contraception from screening through 6 months after the last study drug administration\n9. Any condition judged by the investigator to interfere with compliance with study procedures, restrictions, or requirements","19 Years",{"count":455,"type":21},50,[25],"This study aims to evaluate the efficacy and safety of lenvatinib as first-line therapy in patients with Child-Pugh class B HCC who are unsuitable for curative treatment.",[28],[460,461],"Lenvatinib","child Pugh B","NOT_YET_RECRUITING","2026-01-05",{"date":465,"type":36},"2026-01-07",{"date":467,"type":21},"2026-02",{"date":469,"type":21},"2028-05",{"name":471,"class":472},"National Cancer Center, Korea","OTHER_GOV",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":479,"enrollmentInfo":480,"targetDuration":4,"studyType":22,"phases":482,"briefSummary":483,"conditions":484,"keywords":485,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":212},"100568112","phase-1-clinical-trial-of-autologous-cd19-car-t-cells-cnct19-therapy-for-advanced-hepatocellular-carcinoma-100568112","NCT06676982","Clinical Trial of Autologous CD19 CAR-T Cells (CNCT19) Therapy for Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Aged 18 to 80 years, male or female;\n* Subjects voluntarily participated in the research and signed the Informed Consent Form (ICF) by themselves or their guardians;\n* Pathologically diagnosed with hepatocellular carcinoma, patients with China liver Cancer Staging (CNLC) stageII-III.;\n* HCC patients who are not suitable for surgical resection or local treatment (including ablation therapy, interventional therapy, and radiation therapy), or who experience recurrence or progression after surgery and\u002For local treatment, and who have previously received at least second-line systematic standardized treatment and have progressed or are intolerant to it;\n* According to RECIST 1.1 standard, there should be at least one measurable tumor lesion;\n* Tumor samples that meet the requirements (paraffin blocks or unstained sections with a quantity that meets the testing requirements specified in this study) within 2 years, and have CD19\u002FCD68 double positive cells detected by immunohistochemistry or immunofluorescence;\n* Child-Pugh ≤ 7 and no history of hepatic encephalopathy;\n* ECOG 0-1;\n* Expected survival period ≥ 12 weeks;\n* The toxicity caused by previous treatment has stabilized or recovered to ≤ level 1 (except for cases judged by the researcher to be clinically insignificant)\n\nExclusion Criteria:\n\n* Active brain metastasis;\n* Patients who have received or are waiting for organ transplantation;\n* Active autoimmune diseases that require systemic immunosuppressive therapy within the past 2 years, such as systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, etc;\n* Researchers evaluated that the proportion of intrahepatic tumors is greater than 50% of the entire liver; Or there may be tumor thrombus formation in the main portal vein, or tumor thrombus invasion into the mesenteric vein\u002Finferior vena cava;\n* Use any of the following drugs or treatment methods within the specified time before cell collection: a Received local treatments such as surgical intervention, radiation therapy, ablation, etc. for the studied disease within 4 weeks prior to cell collection; b. Patients who have undergone major surgical procedures or significant trauma within 4 weeks prior to cell collection, or who are expected to undergo major surgery during the study period; c. Received immunotherapy such as anti-PD-1 and PD-L1 within one week prior to cell collection; d. Received chemotherapy drugs or targeted therapy such as sorafenib, regorafenib, lenvatinib within 2 weeks prior to cell collection; e. Used therapeutic doses of corticosteroids within 3 days prior to cell collection, but allowed to use topical and inhaled corticosteroids;\n* Within the past 5 years or simultaneously with other incurable malignant tumors, except for cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast;\n* Individuals who have received other cell therapies or gene modified cell therapies in the past;\n* Central nervous system diseases that have clinical significance in the past or screening, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia\u002Fhemorrhage\u002Fcerebral infarction), cerebral edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychiatric disorders;\n* There are chronic obstructive pulmonary disease, interstitial lung disease, and clinically significant abnormalities in lung function tests;\n* After evaluation by the researchers, it was found that the subject had a large amount of uncontrollable serous fluid accumulation (such as pleural effusion, abdominal effusion, pericardial effusion).","80 Years",{"count":481,"type":21},12,[24],"A phase I clinical study of the safety and tolerability, efficacy of CNCT19 CAR T-cell therapy in patients with advanced hepatocellular carcinoma hepatocellular carcinoma.",[28],[28,486,487,488],"CAR-T","CD19","Tumor-associated macrophage","2025-12-12",{"date":491,"type":36},"2025-12-15",{"date":493,"type":36},"2025-01-10",{"date":495,"type":21},"2026-08-31",{"name":497,"class":43},"Zhejiang University",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":505,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":511,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":526},"100463678","phase-3-study-of-adi-peg-20-versus-placebo-in-subjects-with-high-arginine-level-and-unresectable-hepatocellular-carcinoma-100463678","NCT05317819","Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma","A Randomized, Double-Blind, Multi-Center Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Prior diagnosis of HCC confirmed by radiology, histology, or cytology.\n2. Prior treatment with at least 1 systemic agent for Child-Pugh A subjects. However, Child-Pugh B7 subjects without prior systemic treatment may be enrolled, if they are not eligible for any approved systemic therapies (e.g., due to financial factors).\n3. Plasma arginine ≥ 78 μM at pre-screening visit.\n4. Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapies are eligible, provided that they have either a target lesion which has not been treated with local therapy and\u002For the target lesion(s) within the field of the local regional therapy has shown an increase of ≥ 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan.\n5. Child-Pugh (cirrhosis status) score class A-B7 (Appendix C).\n6. Barcelona Cancer of the Liver (BCLC) stage C (Appendix B)\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment (Appendix D).\n8. Expected survival of at least 3 months.\n9. Age \\>18 years.\n10. Fully recovered from prior surgery, radiation, or chemotherapy, and none within 2 weeks prior to week 1 visit. Liver biopsy for HCC confirmation is allowed.\n11. Female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study and for 35 days after last dose of ADI-PEG 20\u002Fplacebo. Male partners of female subjects and female partners of male subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study if they are of childbearing potential. Females of childbearing potential must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study. If positive HCG pregnancy test, further evaluation to rule out pregnancy must be performed according to GCP before this subject is deemed eligible. Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual period for at least 12 months).\n12. Informed consent must be obtained prior to study initiation.\n13. No concurrent investigational studies are allowed.\n14. Total bilirubin \\\u003C 3.0 mg\u002FdL and no evidence of bile obstruction.\n15. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x upper limit of normal range.\n16. Serum albumin level ≥ 3.0 g\u002Fdl.\n17. Prothrombin time (PT)-international normalized ratio (INR): PT \\\u003C3 seconds above control or INR \\\u003C1.7.\n18. Absolute neutrophil count (ANC) \\>1,500\u002FµL.\n19. Platelets \\>50,000\u002FµL.\n20. Serum uric acid ≤ 8 mg\u002FdL (with or without medication control).\n21. Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine \\>1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 40 mL\u002Fmin.\n22. Subjects with active hepatitis B or C on anti-viremic compounds may remain on such treatment, except for interferon.\n23. Encephalopathy - none or mild (grade 1 or 2, by Child-Pugh classification); lactulose of other supportive care allowed.\n24. Ascites - absent or slight (by Child-Pugh classification); diuretic therapy allowed.\n\nExclusion Criteria:\n\n1. Candidate for potential curative therapies (i.e., resection or transplantation) or eligible for approved systemic therapies according to the labeling of such drugs.\n2. Prior allograft transplantation including liver transplantation.\n3. Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies, except for Grade 1 alopecia.\n4. Serious infection requiring treatment with intravenous, systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.\n5. Pregnancy or lactation.\n6. Expected non-compliance.\n7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.\n8. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the investigator will not affect patient outcome.\n9. Subjects who had been treated with ADI-PEG 20 previously.\n10. History of uncontrolled seizure disorder not related to underlying cancer.\n11. Allergy to pegylated compounds.\n12. Allergy to E. coli drug products (such as GMCSF).\n13. Bleeding esophageal or gastric varices within the prior three months, except if banded or treated.\n14. Uncontrolled ascites (defined as not easily controlled with diuretic treatment).\n15. Having received any blood transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days prior to screening laboratories or after screening laboratories have been obtained until week 1 visit.\n16. Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.","99 Years",{"count":507,"type":21},300,[55],"Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC",[174,28],[175,512,513,514,515,516],"Genotype","Arginine","Arginine Deiminase","ADI-PEG 20","pegargiminase","2025-12-10",{"date":519,"type":36},"2025-12-18",{"date":521,"type":36},"2022-03-14",{"date":523,"type":21},"2028-12",{"name":525,"class":98},"Polaris Group",11,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":539,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":44},"100395542","phase-2-durvalumab-withwithout-tremelimumab-after-palliative-hypofractionated-radiotherapy-for-hepatocellular-carcinoma-100395542","NCT04430452","Durvalumab With\u002FWithout Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma","Phase II Trial of Durvalumab (MEDI4736) With\u002FWithout Tremelimumab for Advanced Hepatocellular Carcinoma After Palliative Hypofractionated Radiotherapy","Inclusion Criteria:\n\n1. Histologically-diagnosed HCC with progression during or after prior PD-(L)1 checkpoint inhibitor immunotherapy (e.g., nivolumab and\u002For pembrolizumab or atezolizumab; prior durvalumab excluded), or without prior PD-(L)1 checkpoint inhibitor immunotherapy.\n\n   a. For patients without prior histologic or cytologic diagnosis, radiographic diagnosis is allowed provided patients meet American Association for the Study of Liver Diseases (AASLD) criteria for radiographic diagnosis.\n2. At least 1 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-measurable tumor present which has not received RT or other local therapy prior to enrollment.\n3. Clinical indication for RT to any site (e.g. painful primary or metastatic tumor, local complication risk such as impending biliary or vascular obstruction).\n4. Child Pugh score of A, B7, or B8 provided other liver function criteria are met.\n5. Eastern Cooperative Oncology Group (ECOG) 0 or 1\n6. Appropriate antiviral therapy for hepatitis B virus (HBV) according to institutional standard of care with HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) \\\u003C 2000 IU\u002FmL.\n7. Adequate organ function as defined below:\n\n   * Hemoglobin \\>= 9.0 g\u002FdL\n   * Absolute neutrophil count \\>= 1,200\u002Fmicroliter (mcL)\n   * Platelet count \\>= 60,000\u002FmcL\n   * Serum bilirubin =\\\u003C 1.5 x institutional upper limit of normal. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician\n   * Aspartate aminotransferase (AST) =\\\u003C 2.5 x institutional upper limit of normal unless liver metastases are present in which case it can be =\\\u003C 5 x upper limit of normal (ULN)\n   * International normalized ratio (INR) \\\u003C 1.5\n   * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft Gault formula.\n8. No contraindication to immune checkpoint inhibitor immunotherapy.\n9. No contraindication to RT.\n10. Age \\>=18 years at time of study entry.\n11. Life expectancy of \\>= 12 weeks.\n12. Body weight \\> 30 kg (66.1 pounds).\n13. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n    * Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\n    * Women \\>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\> 1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)\n14. Women of childbearing potential and men must agree to use adequate contraception from the time of screening through the duration of study participation and for at least 6 months after receiving combination of durvalumab plus tremelimumab and 3 months after last dose of durvalumab.\n15. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n16. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the United States (US) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n\nExclusion Criteria:\n\n1. Prior radiotherapy to tumor sites requiring RT which could compromise safety of additional treatments.\n2. Prior radiotherapy to more than 30% of bone marrow or to a wide field within 4 weeks of the first study treatment.\n3. Prior treatment with cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) or PD-L1 inhibitor.\n4. History of allogenic organ transplantation.\n5. On prior PD-1 inhibitor immunotherapy:\n\n   * Any immune-related adverse events with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 grade \\>= 3 on any prior immunotherapy or toxicity that led to permanent discontinuation of prior immunotherapy.\n   * Any AEs while receiving prior immunotherapy not resolved to grade =\\\u003C 1 or resolved to baseline, with the exception of patients with endocrine AE of grade =\\\u003C 2, who are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic\n   * Required the use of additional immunosuppression other than corticosteroids for the management of an AE, experienced recurrence of a grade \\>= 3 AE if previously re-challenged, and currently require maintenance doses of \\> 10 mg prednisone or equivalent per day\n6. Major surgery, liver-directed therapy, or any other anticancer therapy (e.g. chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) less than 4 weeks prior to enrollment\n7. Any other unresolved toxicity NCI CTCAE grade \\>= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n\n   * Patients with grade \\>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician\n   * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician\n8. Concurrent enrollment in another interventional clinical study, except only in the follow-up period of that study.\n9. Participation in another interventional clinical study with an investigational product during the past 4 weeks except only in the follow-up period of that study.\n10. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n    * Patients with vitiligo or alopecia\n    * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n    * Any chronic skin condition that does not require systemic therapy\n    * Patients with celiac disease controlled by diet alone\n    * Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n12. History of another primary malignancy except for:\n\n    * Malignancy treated with curative intent and with no known active disease \\>= 2 years before the first dose of investigational product (IP) and of low potential risk for recurrence\n    * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    * Adequately treated carcinoma in situ without evidence of disease\n13. History of leptomeningeal carcinomatosis.\n14. History of active primary immunodeficiency.\n15. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice).\n16. Known human immunodeficiency virus (HIV) infection.\n17. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab\u002Ftremelimumab. The following are exceptions to this criterion:\n\n    * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    * Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \\[CT\\] scan premedication)\n18. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n19. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening through the duration of study participation and for at least 6 months after receiving combination of durvalumab plus tremelimumab and 3 months after last dose of durvalumab.\n20. Known allergy or hypersensitivity to IP, any of the study drugs, or any of the study drug excipients.\n21. Prior randomization or treatment in a previous durvalumab and\u002For tremelimumab clinical study regardless of treatment arm assignment.\n22. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n23. Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.",{"count":535,"type":21},21,[25],"This phase II trial studies how well standard of care hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with hepatocellular cancer (liver cancer) that has spread to other places in the body (advanced) and that is growing, spreading, or getting worse (progressing). In some patients, cancer cells and immune cells start to express signals that stop the body's immune system from killing the cancer. New drugs being developed, such as durvalumab and tremelimumab, are designed to target and block these signals and may help increase the immune response to prevent or slow down cancer growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may help the immune system work even better. Giving durvalumab with or without tremelimumab after radiation therapy may work better than radiation therapy alone in treating patients with liver cancer.",[28,30,403,412,31,427,432],[540],"Immunotherapy",{"date":542,"type":36},"2025-12-08",{"date":544,"type":36},"2022-02-04",{"date":546,"type":21},"2029-07-31",{"name":548,"class":43},"Mary Feng, MD",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":556,"targetDuration":4,"studyType":22,"phases":557,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":462,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":4},"100608400","early-phase-1-a-study-of-sz1003-injection-in-patients-with-advanced-hepatocellular-carcinoma-100608400","NCT07201064","A Study of SZ1003 Injection in Patients With Advanced Hepatocellular Carcinoma","An Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SZ1003 Injection in Patients With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Aged 18-75 years old, including the boundary value, no gender restriction;\n* Meet the diagnostic criteria for advanced hepatocellular carcinoma established by histopathology and\u002For cytology, and have experienced failure of second-line therapy for advanced HCC (per 2024 CSCO Guidelines for Primary Liver Cancer). Patients must have progressed during or after at least two prior lines of standard systemic therapy (intolerant or refractory), with radiologically documented disease progression. Eligible stages are Barcelona Clinic Liver Cancer stage B or C, or stage IIb\u002FIIIa\u002FIIIb as defined in the 2024 Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (stage-IIb patients must be deemed unsuitable for surgery or TACE);\n* Have at least one measurable or evaluable lesion per RECIST 1.1;\n* GPC3 positivity confirmed by immunohistochemistry on a clinical pathology section;\n* Child-Pugh classification: class A or class B (≤ 7 points) (See Appendix 1 for the Child-Pugh classification table).;\n* ECOG performance status: the score is 0 or 1 (See Appendix 2 for the ECOG-PS scoring table);\n* Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL\u002Fmin by Cockcroft-Gault;\n* Coagulation: INR, APTT, and PT ≤ 1.5 × ULN without anticoagulant therapy.\n* Able to undergo routine peripheral venous blood collection, establish adequate venous access, and have no contraindications to peripheral blood procurement.\n* Women of child-bearing potential must have a negative serum or urine pregnancy test within 14 days before enrollment and agree to use effective non-hormonal contraception (e.g., condoms, non-medicated IUD) throughout the trial to minimize the risk of pregnancy. Men with partners of child-bearing potential and women of child-bearing potential must maintain effective contraception from screening until 12 months after the last cell infusion.\n* Willing to participate in the study, fully informed of the study and sign the informed consent form; willing to comply with all trial procedures.\n\nExclusion Criteria:\n\n* Patients who have previously undergone liver transplantation, organ allotransplantation, allogeneic stem-cell transplantation, and renal-replacement therapy.\n* Clinically detectable hepatic encephalopathy or those requiring pharmacological treatment for hepatic encephalopathy.\n* Moderate-to-severe ascites attributable to portal hypertension or cirrhosis.\n* History of leptomeningeal or central-nervous-system metastases.\n* Neurologic disorder ≥ Grade 2 (CTCAE).\n* Having experienced esophageal or gastric variceal bleeding due to portal hypertension within the past 3 months. Patients with evidence of portal hypertension and a high bleeding risk as assessed by the investigator.\n* Having experienced any life-threatening bleeding events within the past 3 months, including those requiring transfusion, surgery, local treatment, or continuous pharmacological therapy.\n* History of stroke or central nervous system hemorrhage; Prior stroke, CNS hemorrhage, TIA, or RIND within 6 months.\n* Uncontrolled hypertension (SBP \\> 140 mmHg or DBP \\> 90 mmHg despite optimal therapy), hypertensive crisis, or hypertensive encephalopathy.\n* Symptomatic CHF (NYHA ClassII-IV), Symptomatic or poorly controlled arrhythmias. Electrocardiogram (ECG) showing clinically significant abnormalities, or QTc interval ≥ 450 milliseconds in men, ≥ 470 milliseconds in women (≥ 480 milliseconds for subjects with bundle branch block on consecutive ECGs) (calculated using Fridericia's formula).\n* Severe bleeding diathesis, coagulopathy, or ongoing thrombolytic therapy.\n* A history of or current pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, drug-related pneumonitis, or severely impaired pulmonary function.\n* HBsAg-positive subjects with HBV-DNA above the lower limit of detection at the study site must receive at least 7 days of antiviral therapy before the first dose and are willing to continue antiviral treatment for hepatitis B as required during the study to be eligible for enrollment. HBsAg-negative but HBcAb-positive subjects with HBV-DNA below the lower limit of detection at the study site will be closely monitored for HBV-DNA and liver transaminase levels during the dosing period. If HBV reactivation occurs during the treatment period, these subjects must agree to immediately initiate antiviral therapy for hepatitis B to remain eligible. All such subjects must be willing to continue antiviral treatment for hepatitis B for at least 6 months after the last dose, and the investigator may follow up on hepatitis B markers based on individual patient circumstances. Active hepatitis C: HCV antibody-positive with HCV-RNA levels above the lower limit of detection at the study site; co-infection with hepatitis B and hepatitis C.\n* Active tuberculosis (TB), subjects currently receiving anti-TB treatment or those who have received anti-TB treatment within 1 year before the first dose.\n* HIV-positive or active syphilis.\n* Subjects with active or poorly controlled serious infections; those who have had severe infections within 4 weeks before peripheral blood collection, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications.\n* Active autoimmune disease requiring systemic therapy (immunosuppressants, corticosteroids, or DMARDs) within 2 years and not adequately controlled.\n* History of malignancy (other than HCC) within 5 years.\n* Known hypersensitivity to study drug or its components.\n* Pregnant or lactating women.\n* Subjects deemed unsuitable for participation in this trial by the investigator.",{"count":481,"type":21},[558],"EARLY_PHASE1","This study is a \"3+3\" dose-escalation, open-label, multiple-dose clinical trial.",[28],"2025-09-23",{"date":563,"type":36},"2025-10-01",{"date":565,"type":21},"2025-09-25",{"date":567,"type":21},"2027-09-30",{"name":569,"class":98},"Guangdong ProCapZoom Biosciences Co., Ltd.",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":577,"targetDuration":4,"studyType":22,"phases":579,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":44},"100544868","phase-1-study-of-au409-capsule-in-advanced-hepatocellular-carcinoma-patients-who-failed-standard-treatment-100544868","NCT06374485","Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment","A Phase I, Single-arm, Open-label, Dose-escalation, Safety and Pharmacokinetic Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment","Inclusion Criteria:\n\n1. Male or female of 18-75 (inclusive) years of age.\n2. Patients with histologically and\u002For cytologically and\u002For radiologically confirmed advanced (unresectable or metastatic) hepatocellular carcinoma (HCC) that have failed any of standard treatment (including Immunotherapies and\u002For Tyrosine Kinase Inhibitor therapies, or Oxaliplatin-based systemic chemotherapies), recurrence, or are intolerant.\n3. Before treatment initiation, patients must have previously completed chemotherapy, radiotherapy, interventional therapy for more than 4 weeks (except palliative radiotherapy for bone metastasis). And all treatment-related toxicities (except hair loss, pigmentation, and chemotherapy-related neurotoxicities, etc.) have recovered (≤ level 1 or baseline level).\n4. Have at least one evaluable disease lesion based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST).\n5. ECOG score of 0 or 1.\n6. Patients with Child Pugh class A or some class B (≤7 and no hepatic encephalopathy).\n7. Have a life expectancy of \\>12 weeks.\n8. Able to be orally administered.\n9. Laboratory examinations must meet the following criteria within 7 days before treatment initiation:\n\n   * Absolute neutrophil count（ANC）≥1.5 × 109\u002FL，platelets（PLT） count ≥75 × 109\u002FL，hemoglobin（HGB）≥90 g\u002FL，and patients are not allowed to receive blood transfusion or other haematopoietic growth factors within 14 days before treatment initiation.\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be ≤5.0×upper limit of normal (ULN).\n   * Total bilirubin (TBIL) ≤1.5×ULN.\n   * Ablumin (ALB) ≥28g\u002FL.\n   * Serum creatinine (CRE) ≤1.0×ULN, creatinine clearance rate (CCR) ≥60 mL\u002Fmin (Cockcroft-Gault equation).\n   * International normalized ratio（INR）≤1.5，prothrombin time (PT) ≤1.5×ULN.\n10. Have a negative serum pregnancy test for premenopausal women (postmenopausal women who have been menopausal for at least 12 months are considered as infertile). For male patients (including male patients' female spouses of child-bearing potential) and female patients of child-bearing potential must be contraceptive throughout the study and within the 6 months following the last dose of AU409.\n11. Patients voluntarily give written informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Patients of central nervous system metastasis with clinical symptoms (except patients who are asymptomatic, and no disease progression confirmed by MRI diagnosis for more than 28 days).\n2. Allergies to any ingredients or excipients in AU409.\n3. Treatment with other anticancer therapies (including surgery, radiation therapy, chemotherapy, anti-angiogenic therapy, targeted therapy, or radiofrequency ablation therapy, etc.) or investigational therapy (except patients who stop treatment of Chinese patent medicine or Chinese herbal medicine for more than 7 days, or complete palliative radiotherapy for bone metastasis \\>2 weeks) within 28 days prior to the first dosing.\n4. QTc ≥470 msec during screening period (Fridericia's equation) or with a history of congenital long QT syndrome.\n5. Patients with history of gastrointestinal surgery that may change the absorption and activity of drugs in their body (such as total gastrectomy, small bowel resection, external bile shunt, etc.) in combination with refractory hiccups, nausea, vomiting, and other diseases that affect drug absorption (such as peptic ulcer, inflammatory bowel disease, lactose intolerance, malabsorption syndrome or chronic diarrhea, etc.).\n6. Patients who require serous effusion for continuous drainage or drug infusion (such as ascites, pleural effusion, etc.), or have undergone portal vein shunt.\n7. Patients with gastrointestinal perforation and\u002For fistula, abdominal abscess, visceral fistula, intestinal obstruction, hepatic encephalopathy, portal vein and inferior vena cava cancer thrombus within 3 months prior to the treatment initiation.\n8. Patients have gastrointestinal bleeding (including esophageal or gastric varices, local active ulcer lesions, etc.), or have a clear bleeding tendency, or are receiving anticoagulation\u002Fthrombolytic therapy within 3 months before treatment initiation. Positive result of occult blood needs to identifythe causes.\n9. Patients with interstitial lung disease, non-infectious pneumonia.\n10. History of allogeneic stem cell transplantation or organ transplantation.\n11. Patients who receive major surgery (except biopsy and puncture) or with major trauma within 28 days before treatment initiation.\n12. Patients with infectious diseases that affect daily activities or require systemic treatment (such as the use of hormones, antibiotics, antifungal drugs, antiviral drugs, and oxygen inhalation), including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.\n13. Uncontrolled diseases, including a) New York Heart Association (NYHA) Class II or higher heart failure, b) Severe\u002Funstable angina pectoris, c) Primary cardiomyopathy, d) Myocardial infarction or coronary\u002Fperipheral artery bypass surgery occurred within 6 months before treatment initiation, e) Uncontrollable high blood pressure, f) Severe arrhythmia requiring medication or intervention, g) Echocardiographic left ventricular ejection fraction \\\u003C50% during the screening period, h) Deep vein thrombosis\u002Farterial thrombosis \u002FPulmonary vein embolism occurred within 2 months before treatment initiation, i) Cerebrovascular accident or transient ischemic attack occurred within 6 months before treatment initiation, j) Ocular lens disease (such as cataract), k) Diabetes that has not been effectively controlled, l) Thyroid diseases that have not been effectively controlled, m) Urine protein≥2+ and quantity of 24-hour urine protein ≥1.0g.\n14. Human immunodeficiency virus infection (HIV 1\u002F2 antibody positive).\n15. HBV infection (HBsAg positive and HBV DNA ≥2000 IU\u002FmL); Hepatitis C virus (HCV) antibody is positive and HCV RNA\\>103 copies\u002Fml; HBsAg and HCV antibodies are both positive.\n16. Patients with tuberculosis (TB) who need to receive\u002Fare receiving anti-TB treatment within 1 year before treatment initiation.\n17. Pregnant or nursing；\n18. Patients complicated with other malignant tumors within 5 years before treatment initiation, except various in situ tumors, skin basal cell carcinoma or squamous cell carcinoma that have been cured in the past, local prostate cancer receiving radical operation, and in situ breast ductal carcinoma receiving radical operation.\n19. Patients with other severe, acute, chronic, or psychiatric illnesses that may increase the risk of treatment or may interfere with interpretation of the trial results. And patients with alcoholism, smoking addiction, drug abuse, and other circumstances that are not conductive to the treatment or explain adverse events, thereby contributing to decrease study compliance.\n20. Other conditions that are not suitable for participating in the study in the opinion of investigator.\n21. Patients who were treated with pentamidine prior to treatment initiation or during the study.",{"count":578,"type":21},18,[24],"This study is a Phase I, dose-escalation study of AU409 in advanced hepatocellular carcinoma patients who failed standard treatment. A '3+3' dose-escalation design will be utilized to gradually increase the dose of AU409, aiming to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of multi-dose AU409 in patients with advanced HCC.",[28],"2025-08-19",{"date":584,"type":36},"2025-08-26",{"date":586,"type":36},"2024-05-21",{"date":588,"type":21},"2025-12-31",{"name":590,"class":98},"Lee's Pharmaceutical Limited",{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":479,"enrollmentInfo":598,"targetDuration":4,"studyType":600,"phases":4,"briefSummary":601,"conditions":602,"keywords":605,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":44},"100540940","locoregional-therapy-combined-with-bevacizumab-and-pd1l1-inhibitor-in-advanced-hepatocellular-carcinoma-100540940","NCT06323382","Locoregional Therapy Combined With Bevacizumab and PD1\u002FL1 Inhibitor in Advanced Hepatocellular Carcinoma","Efficacy of Locoregional Therapy Combined With Bevacizumab and PD1\u002FL1 Inhibitor in Advanced Hepatocellular Carcinoma: a Multicenter, Observational, Real-world Study","Inclusion Criteria:\n\n1. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;\n2. age between 18 and 75 years;\n3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage).\n4. Locoregional therapy include TACE or HAIC, locoregional combined with Bevacizumab and PD1\u002FL1 inhibitor as firstline therapy; non-firstline therapy (previous use of any systemic therapy but intolerant or drug resistant).\n5. Child-Pugh class A or B;\n6. Eastern Cooperative Group performance status (ECOG) score of 0-2;\n7. Hemoglobin ≥ 8.5 g\u002FdL Total bilirubin ≤ 30mmol\u002FL Serum albumin ≥ 32 g\u002FL ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT\u002FAPTT within normal limits Absolute neutrophil count (ANC) \\>1,500\u002Fmm3\n8. Prothrombin time ≤18s or international normalized ratio \\\u003C 1.7.\n9. Ability to understand the protocol and to agree to and sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Cholangiocellular carcinoma (ICC).\n2. Patients without image information should be excluded;\n3. The survival or patients less than 3 months.\n4. Serious medical comorbidities.\n5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy.\n6. Known history of HIV.\n7. History of organ allograft.\n8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.\n9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\n10. Evidence of bleeding diathesis.\n11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.",{"count":599,"type":21},240,"OBSERVATIONAL","Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1\u002FL1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy.",[28,603,604],"Anti-PD1\u002FPDL1 Antibody","Bevacizumab",[604,606,607,608,609,610],"Atezolizumab","Tislelizumab","Toripalimab","Sintilimab","Camrelizumab","2025-08-10",{"date":613,"type":36},"2025-08-14",{"date":615,"type":36},"2021-01-01",{"date":617,"type":21},"2025-12-30",{"name":619,"class":43},"Sun Yat-sen University",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":22,"phases":629,"briefSummary":630,"conditions":631,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":641},"100500557","phase-1-a-study-of-tegavivint-bc2059-in-patients-with-advanced-hepatocellular-carcinoma-100500557","NCT05797805","A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma","A Phase 1\u002F2 Exploratory Study of the TBL1 Inhibitor, Tegavivint (BC2059), in Patients With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Male or female, 18 years of age or older\n* Confirmed diagnosis of HCC by either:\n\nHistologically or cytologically documented HCC based on pathology report or Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria\n\n* Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach\n* Child-Pugh class A or ≤ 7 class B liver score (no hepatic encephalopathy) within 7 days of first dose of the investigational product(s)\n* Disease progression, intolerance or contraindication to at least one line of systemic therapy for advanced HCC Prior treatment with cabozantinib or lenvatinib is allowed in the combination dose escalation and expansion parts of the study.\n* Measurable disease as defined by RECIST 1.1 with spiral computerized tomography (CT) scan or magnetic resonance imaging (MRI). Lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if progression has been demonstrated in such lesions.\n* Willingness and ability to provide tumor biopsies during screening and while on treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of the investigational product(s)\n* Patients must have organ and marrow function as defined below within 7 days of the first dose of the investigational product(s):\n\n  * Absolute neutrophil count (ANC) ≥ 1.2 x 109\u002FL\n  * Platelets ≥ 60 x 10\\^9\u002FL; no transfusion within 7 days prior to assessment\n  * Hemoglobin ≥ 9 g\u002FdL (red blood cell transfusion or growth factors support is not allowed in the 14 days prior to the screening laboratory assessment)\n  * Total bilirubin ≤ ULN\n  * AST and ALT ≤ 5 x ULN\n  * Renal Function : Estimated creatinine clearance (CrCl) ≥ 50 mL\u002Fmin by the Cockcroft-Gault equation using actual body weight, or Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL\u002Fmin\u002F1.73m2 by CKD-EPI Creatinine Equation, or Measured creatinine clearance ≥ 50 mL\u002Fmin\n  * Albumin ≥ 2.8 g\u002FdL\n  * International normalized ratio (INR) ≤ 1.7, unless the patient is receiving anticoagulant therapy as long as the patient is within therapeutic range of intended use of anticoagulants\n* Washout period prior to Day 1 of Cycle 1:\n\n  * At least 21 days from the last dose of prior systemic anticancer treatment\n  * At least 14 days from palliative radiotherapy (≤ 10 fractions or ≤30 gray \\[Gy\\] total dose or at least 28 days from radiotherapy \\> 30 Gy) to extrahepatic tumor lesions\n  * At least 28 days from local or loco-regional therapy of intrahepatic tumor lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)\n* Grade ≤ 1 toxicity due to any previous cancer therapy according to the NCI-CTCAE, v.5. Grade 2 is allowed in case of alopecia and\u002For peripheral sensory neuropathy.\n* Participants with past HCV infection will be eligible for the study. The treated participants must have completed their treatment at least 1 month prior to starting study intervention and HCV viral load must be below the limit of quantification.\n* Participants with controlled HBV will be eligible if they meet the following criteria:\n\n  * Antiviral therapy for HBV must be given for at least 4 weeks and HBV viral load must be less than 500 IU\u002FmL prior to first dose of study drug. Patients on active HBV therapy with viral loads under 100 IU\u002FmL should stay on the same therapy throughout study intervention.\n  * Patients who are positive for anti-hepatitis B core antibody HBc, negative for hepatitis B surface antigen (HBsAg), and negative or positive for anti-hepatitis B surface antibody (HBs), and who have an HBV viral load under 100 IU\u002FmL, do not require HBV antiviral prophylaxis.\n  * Patients must have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤ 150\u002F90 mm Hg at Screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1.\n\nExclusion Criteria:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* Patients receiving therapy with other anti-neoplastic or experimental agents\n* Patients receiving concomitant strong inhibitors of CYP3A4\u002F5 that cannot be discontinued 7 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n* Patients receiving concomitant inducers of CYP3A4\u002F5 that cannot be discontinued at least 14 days prior to Cycle 1 Day 1.\n* Patients with known history of Gilbert's syndrome or other genetic conditions affecting UGT1A1 function.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to tegavivint, or other agents used in study\n* Malignant disease, other than that being treated in this study. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded. Other exceptions include malignancies that were treated curatively and have not recurred within 3 years prior to Cycle 1 Day 1 and any malignancy considered indolent and that has never required therapy.\n* Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples\n* Known central nervous system (CNS) involvement\n* Uncontrolled concurrent illness including, but not limited to:\n\n  * Ongoing or active infection (exception: HBV infection - see inclusion criteria)\n  * Unhealed wounds or presence of any external drainage\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements; discuss with Medical Monitor if there are any questions\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including any of the following:\n\n  * Congestive heart failure, NYHA \\> Class II\n  * Left ventricular ejection fraction \\\u003C 50%\n  * Unstable angina pectoris or cardiac arrhythmia\n  * Baseline QTc (Fridericia) ≥ 450 milliseconds. In the event a QTc (Fridericia) measurement is not possible due to factors such as a pacemaker or bundle branch block, the patient may be evaluated by a cardiologist who must document no apparent increased risk for Torsades de Point or other morbidity associated with prolonged QTc. With such documentation, the patient may be eligible based with additional Medical Monitor review.\n  * Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome\n  * Myocardial infarct within 6 months before Cycle 1 Day 1\n  * Clinically significant pericardial disease\n* Any major surgery within 21 days prior to Cycle 1 Day 1. Major surgery is defined as any significantly invasive procedure into a major body cavity (abdomen, cranium etc.) and\u002For surgery requiring extensive recuperation (joint replacement). Please discuss with the Medical Monitor if there are any questions.\n* Pregnant and breastfeeding women are excluded from this study. The effects of tegavivint on the developing human fetus have the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with tegavivint\n* Women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use one highly effective method of contraception, including hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device or intrauterine system; vasectomy or tubal ligation; and one effective method of contraception, including male condom, female condom, cervical cap, diaphragm or contraceptive sponge or abstaining from sex for the duration of study participation and for at least 4 months following completion of tegavivint and pembrolizumab (if applicable) administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for PK interactions with tegavivint.\n* Exclusions for patients treated on study with cabozantinib or lenvatinib:\n\n  * Patients with large esophageal varices at risk of bleeding that are not being treated with conventional medical intervention: beta blockers or endoscopic treatment. Assessment of esophageal varices for patients in whom conventional medical intervention for known esophageal varices is already in place should be performed by endoscopy as per local standard of care.\n  * Uncontrolled hypertension (systolic blood pressure \\>150 mmHg or diastolic pressure \\>90 mmHg despite optimal medical management).\n  * Persistent proteinuria of NCI-CTCAE version 5.0 grade 3 or higher. Urine dipstick result of 3+ is allowed if protein excretion (estimated by urine protein\u002Fcreatinine ratio on a random urine sample) is \\\u003C3.5 g\u002F24 hours.\n  * Clinically significant bleeding NCI-CTCAE version 5.0 grade ≥ 3 within 30 days before randomization.\n  * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months before the start of study medication.\n  * Patients treated with medications with a known potential to prolong the QT\u002FQTc interval.\n  * Hypersensitivity or intolerance to cabozantinib (patients with hypersensitivity or intolerance to cabozantinib may enroll in treatment arms exploring tegavivint plus lenvatinib if they did not have hypersensitivity or intolerance to lenvatinib).\n  * Hypersensitivity or intolerance to lenvatinib (patients with hypersensitivity or intolerance to lenvatinib may enroll in treatment arms exploring tegavivint plus cabozantinib if they did not have prior hypersensitivity or intolerance to cabozantinib)",{"count":628,"type":21},178,[24,25],"This study will be conducted in 2 parts. The first part is a phase 1 single-agent dose escalation, and dose optimization, study of tegavivint in patients with advanced HCC after failure of at least one line of prior systemic therapy. The second part of the study will begin with a brief dose escalation part for each combination (tegavivint plus cabozantinib or tegavivint plus lenvatinib) followed by a combination dose expansion.",[28],"2025-07-01",{"date":634,"type":36},"2025-07-04",{"date":636,"type":36},"2023-09-13",{"date":638,"type":21},"2026-06",{"name":640,"class":98},"Iterion Therapeutics",8,{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":22,"phases":650,"briefSummary":651,"conditions":652,"keywords":653,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":44},"100548258","early-phase-1-a-clinical-trial-evaluating-the-safety-and-efficacy-of-intravenous-cd-801-in-treating-advanced-hcc-patients-100548258","NCT06418659","A Clinical Trial Evaluating the Safety and Efficacy of Intravenous CD-801 in Treating Advanced HCC Patients","A Clinical Trial Assessing the Safety and Efficacy of Intravenous CD-801 for the Treatment of Patients With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Males or females, aged 18 years or older.\n2. Subjects must have confirmed diagnosis of HCC with any of the following criteria according to the American Association for the Study of Liver Diseases criteria.\n3. Unresectable HCC.\n4. Subjects were not eligible for locoregional or systemic therapies, or had disease progression, or would not benefit after at least one of the conventional therapies.\n5. According to mRECIST, subjects should be with at least 1 measurable target lesion.\n6. Life expectancy of 12 weeks or more.\n7. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.\n8. Males with fertility and females of childbearing potential are willing to use a highly effective method of contraception for the entire study period and for 6 months after study drug discontinuation. Females of childbearing age, including premenopausal females and within 2 years after menopause, must have a negative serum pregnancy test result within 7 days prior to the first dose of study treatment.\n9. Subjects who had a voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.\n\nExclusion Criteria:\n\n1. Inadequate liver function：Albumin (ALB) \\\u003C 25 g\u002FL, or total bilirubin \\> 5 × the upper limit of normal (ULN), or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \\>10 × ULN.\n2. Inadequate renal function defined as creatinine \\>1.5 × ULN or calculated creatinine clearance \\\u003C 40 mL\u002Fmin.\n3. Absolute neutrophil count (ANC) \\\u003C 1.0×109\u002FL, or Platelets \\\u003C 30×109\u002FL, or Hemoglobin \\\u003C 8.5 g\u002FdL.\n4. International Normalized Ratio (INR) \\> 2.3.\n5. Subjects with a history of liver transplantation.\n6. Subjects with poorly controlled hypertension, diabetes or other serious heart or lung diseases, or with serious dysfunction.\n7. Subjects with extrahepatic metastasis who had not received first-line systemic therapies (excluding those who are not eligible for systemic therapies) or who were receiving effective systemic therapy currently.\n8. Subjects who had prior anticancer treatment with any locoregional therapies, antiangiogenic targeted therapies, immune checkpoint inhibitors or chemotherapy (within 4 weeks, or within 2 weeks in case of sorafenib), radiotherapy (within 3 weeks), or active traditional Chinese medicine (within 2 weeks) before the first dose of study treatment, except for the treatments after which the disease still progressed according to mRECIST.\n9. All toxicities related to prior locoregional or systemic anti-tumor treatments are still grade 2 or more (except for hair loss and other events that have been judged tolerable by researchers).\n10. Subjects with complication histories of liver cirrhosis or HCC such as gastrointestinal hemorrhage, overt hepatic encephalopathy, or refractory ascites within 2 weeks prior to the first dose of study treatment.\n11. Uncontrolled active infection (eg, lung infections, or abdominal infections).\n12. History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate \\> 90%), such as adequately treated early gastric carcinoma, carcinoma in situ of the cervix, non-melanoma skin carcinoma, or localized prostate cancer.\n13. HBV DNA greater than 500 copies\u002FmL, or HCV RNA greater than 15 U\u002FmL.\n14. Subject is positive for Human Immunodeficiency Virus (HIV).\n15. Any subject who is allergic to MRI contrast agents.\n16. Pregnant\u002Flactating women, or women who have the possibility of pregnancy.\n17. Participation in other investigational drug trials within 4 weeks prior to initiation of this study treatment.\n18. Any medical or other condition which, in the opinion of the investigator, would preclude participation in this clinical trial.",{"count":5,"type":21},[558],"The goal of this investigator-initiated, a single-arm, open-label, pilot study is to investigate the safety, tolerability, and efficacy of Intravenous CD-801 treatment in subjects with advanced hepatocellular carcinoma(HCC).\n\nCondition of disease: advanced hepatocellular carcinoma.\n\nIntervention： CD-801 will be administered intravenously for the treatment of HCC. The dosing regimen is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response. The trial is structured in two phases: dose escalation and dose expansion.\n\nDose Escalation Phase:\n\nThe study employs a i3+3 design to assess escalating CD-801 dosages: 25 μg, 50 μg, and 100 μg. Post-initial dose, a 14-day DLT observation will evaluate tolerability and safety, guiding dose adjustments or selection of the Recommended Dose (RD) for the expansion phase. Cohorts may include up to 9 participants, adjusted for safety.\n\nDose Expansion Phase:\n\nThe expansion phase will use the safe dosage and regimen from the escalation phase, with treatments starting 14 ± 3 days after the initial dose, then every 28 ± 7 days, adjusted as needed. It ends upon complete response, disease progression, toxicity, withdrawal, loss to follow-up, new oncological treatments, or investigator termination, with a final assessment 14 days post-last dose. The phase plans to enroll about 10 participants to further assess CD-801's safety, tolerability, and antitumor effects using mRECIST.\n\nDrug: CD-801, a drug specifically designed to target liver cancer cells and facilitate the expression of HNF4α.\n\nAccording to Amendment 1, in these two phases, patients who have received at least 4 cycles of HNF4α srRNA (CD-801 or CD-GA-102) therapy and have a tumor assessment of SD (stable disease) or PD (progressive disease) per mRECIST criteria may, after a comprehensive evaluation by the investigator considering the patient's treatment history and the current safety and efficacy data of HNF4α srRNA, continue HNF4α srRNA at the same dose, or have their dose adjusted, in combination with immunotherapy, targeted therapy, or chemotherapy.",[28],[654,655],"Hepatocellular carcinoma","Hepatocyte nuclear factor 4α","2025-04-21",{"date":658,"type":36},"2025-04-24",{"date":660,"type":36},"2024-10-12",{"date":662,"type":21},"2026-12",{"name":664,"class":43},"Shanghai Changzheng Hospital",{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":670,"acronym":4,"eligibilityCriteria":671,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":672,"targetDuration":4,"studyType":22,"phases":673,"briefSummary":674,"conditions":675,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":44},"100443702","phase-2-cryoablation-combined-with-tislelizumab-plus-lenvatinib-as-second-line-or-later-therapy-in-advanced-hepatocellular-carcinoma-100443702","NCT05057845","Cryoablation Combined with Tislelizumab Plus Lenvatinib As Second-line or Later Therapy in Advanced Hepatocellular Carcinoma","A Phase II Study of Cryoablation Combined with Tislelizumab Plus Lenvatinib As Second-line or Later Therapy in Patients with Advanced Hepatocellular Carcinoma (CASTLE-02)","Inclusion Criteria:\n\n* Written informed consent obtained.\n* Age ≥ 18 years at time of study entry.\n* Participants must have unresectable or metastatic histologically or cytologically confirmed hepatocellular carcinoma\n* Participants must have failed 1 line of systemic regimens for advanced hepatocellular carcinoma due to disease progression or toxicity.\n* Patients had been refractory or intolerant to previous systemic chemotherapy (oxaliplatin-based chemotherapy), targeted therapy (eg, sorafenib or lenvatinib), or anti-PD-1 or anti-PD-L1 based regimen.\n* At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.\n* Performance status (PS) ≤ 2 (ECOG scale).\n* Life expectancy of at least 12 weeks.\n* Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500\u002FL, platelets ≥75 x103\u002FL; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g\u002FdL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (if using the Cockcroft-Gault formula )\n* Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n* History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment\n* Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.\n* Prior treatment with cryoablation.\n* RFA and resection administered less then 4 weeks prior to study treatment start.\n* Radiotherapy administered less then 4 weeks prior to study treatment start.\n* Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.\n* Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.\n* Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.\n* Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to:\n\n  1. history of interstitial lung disease\n  2. Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)\n  3. known acute or chronic pancreatitis\n  4. active tuberculosis\n  5. any other active infection (viral, fungal or bacterial) requiring systemic therapy\n  6. history of allogeneic tissue\u002Fsolid organ transplant\n  7. diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Tislelizumab treatment.\n  8. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma\u002Fatopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study.\n  9. Live vaccine within 30 days prior to the first dose of Tislelizumab treatment or during study treatment.\n  10. History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of Tislelizumab treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS\n* Medication that is known to interfere with any of the agents applied in the trial.\n* Any other efficacious cancer treatment except protocol specified treatment at study start.\n* Patient has received any other investigational product within 28 days of study entry.\n* Female subjects who are pregnant, breast-feeding or male\u002Ffemale patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). \\[Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner\\]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.",{"count":7,"type":21},[25],"The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Tislelizumab plus lenvatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma.",[28],"2025-02-25",{"date":678,"type":36},"2025-02-27",{"date":680,"type":36},"2021-09-26",{"date":682,"type":21},"2026-09-20",{"name":684,"class":43},"Fudan University",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":4,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":692,"targetDuration":4,"studyType":22,"phases":694,"briefSummary":696,"conditions":697,"keywords":699,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":701,"lastUpdatePostDateStruct":702,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":44},"100562953","dtace-haic-combined-with-bevacizumab-and-atezolizumab-for-huge-hepatocellular-carcinoma-100562953","NCT06609863","dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma","dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Intermediate and Advanced Hepatocellular Carcinoma: a Prospective Phase II Study","Inclusion Criteria:\n\n1. Clinical diagnosis of HCC.\n2. Age between 18 and 75 years;\n3. The maximum tumor size ≥10 cm;\n4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III\n5. limited metastases (≤5).\n6. Child-Pugh class A or B;\n7. Eastern Cooperative Group performance status (ECOG) score of 0-1;\n8. Hemoglobin ≥ 8.5 g\u002FdL Total bilirubin ≤ 30mmol\u002FL Serum albumin ≥ 32 g\u002FL ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT\u002FAPTT within normal limits Absolute neutrophil count (ANC) \\>1,500\u002Fmm3\n9. Prothrombin time ≤18s or international normalized ratio \\\u003C 1.7.\n10. Ability to understand the protocol and to agree to and sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Diffuse HCC;\n2. Extrahepatic metastasis \\>5;\n3. Obstructive PVTT involving mesenteric vena cava (PVTT IV).\n4. Serious medical comorbidities.\n5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy\n6. untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding.\n7. Eastern Cooperative Group performance status (ECOG) score of ≥2;\n8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.\n9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy\n10. Evidence of bleeding diathesis.\n11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.",{"count":693,"type":21},27,[695],"NA","This study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.",[28,606,604,698],"Chemotherapy",[700,606,604],"hepatocellular carcinoma","2024-12-01",{"date":703,"type":36},"2024-12-03",{"date":705,"type":36},"2024-10-01",{"date":707,"type":21},"2026-06-30",{"name":619,"class":43},{"id":710,"slug":711,"hasResults":12,"nctId":712,"briefTitle":713,"officialTitle":714,"acronym":4,"eligibilityCriteria":715,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":479,"enrollmentInfo":716,"targetDuration":4,"studyType":600,"phases":4,"briefSummary":718,"conditions":719,"keywords":724,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":701,"lastUpdatePostDateStruct":728,"startDateStruct":729,"completionDateStruct":731,"leadSponsor":732,"locationsCount":44},"100565611","ablation-of-pulmonary-oligometastasis-combined-with-system-for-advanced-hepatocellular-carcinoma-100565611","NCT06644430","Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma","Ablation of Pulmonary Oligometastasis Combined With System Compared System Therapy for Advanced Hepatocellular Carcinoma: a Multicenter Retrospective Study","Inclusion Criteria:\n\n1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;\n2. presence of pulmonary oligometastasis, the metastases found within three month of HCC diagnosis;\n3. metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;\n4. receipt of first-line systemic therapy for minimum of 3 months before ablation, with controlled intrahepatic tumors and no progression of metastases. Controlled intrahepatic tumors were defined as those showing a partial or stable response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST);\n5. undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) were included;\n6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n7. no history of other malignancies.\n8. life expectancy more than 3 months;\n9. agreed to participated in this clinical trial;\n10. Hemameba ≥3.0 x109\u002FL, neutrophil ≥1.5x109\u002FL, hemoglobin≥10.0 g\u002FL, platelet≥100x 109\u002FL, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml\u002Fmin.\n\nExclusion Criteria:\n\n1. intermediate HCC;\n2. age \\\u003C 18 years or \\> 75 years;\n3. advanced HCC with more than five metastases;\n4. no response to Lenvatinib;\n5. metastases size \\> 5 cm;\n6. life expectancy less than 3 months.",{"count":717,"type":21},470,"Ablation has been an effective therapy in treating intrathoracic metastases. However, for hepatocellular carcinoma with pulmonary oligometastasis, ablation of metastases remains relatively unexplored and still needs clinical evidence.",[28,720,721,722,723],"Lung Cancer","Oligometastasis","Ablation","Systemic Therapy",[725,460,726,610,607,609,608,727],"Advanced hepatocellular carcinoma","Sorafeinib","Apatinib",{"date":703,"type":36},{"date":730,"type":36},"2024-10-04",{"date":617,"type":21},{"name":619,"class":43}]