[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable-hepatocellular-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable-hepatocellular-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,71,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100627255","early-phase-1-thio-and-cadonilimab-in-resectable-hepatocellular-carcinoma-100627255",false,"NCT07446257","THIO and Cadonilimab in Resectable Hepatocellular Carcinoma","A Phase Ib Open-label, Randomized Trial Evaluating Neoadjuvant Ateganosine and Cadonilimab in Resectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Diagnosis of HCC confirmed by histology or according to the American Association for the Study of Liver Disease (AASLD) criteria\n\n   a. Availability of tumor tissue samples prior to the first day of study treatment is required for all patients.\n2. HCC that is amenable to R0 resection with curative intent as determined by treating surgical\u002Fmedical oncologists in consultation with the principal investigator. Subject must be a suitable candidate for surgery based on evaluations by the treating surgeon\u002Foncologist.\n3. Measurable disease according to RECIST 1.1\n4. No prior anti-PD (Programmed death)-1\u002FL1 therapies for any indication\n5. Age ≥18\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n7. Child Pugh A\n8. Adequate organ and marrow function as defined below:\n\n   1. ANC (absolute neutrophil count) ≥ 1.5 x 109\u002FL (does not apply to patients with benign ethnic neutropenia)\n   2. Platelets ≥ 75 x 109\u002FL without transfusion\n   3. Hemoglobin ≥ 9 g\u002FdL without transfusion within 2 weeks of screening\n   4. ALT (Alanine Aminotransferase) ≤ 3 2 x ULN (Upper Limit of Normal)\n   5. Bilirubin ≤ 3 x ULN\n   6. Creatinine clearance ≥ 50 mL\u002Fmin calculated by the Cockcroft-Gault formula using actual body weight\n9. All etiologies of chronic liver disease including but not limited to Hepatis C Virus (HCV) or Hepatis B Virus (HBV) infection. HCV and HBV infection status does not preclude eligibility as long as patients meet all other eligibility criteria but must be known prior to starting treatment. Patients with HBV must be on anti-viral therapy prior to the first day of investigational drug treatment. Patients with HCV may include active or resolved infection.\n10. All men, as well as women of child-bearing potential 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 for 3 months following the last dose of ateganosine or 4 months following the last dose of cadonilimab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\n    A 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    * 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).\n11. Ability to understand and the willingness to sign a written informed consent.\n12. Willing and able to comply with the requirements and restrictions in this protocol.\n\nExclusion Criteria:\n\n1. Presence of extrahepatic extension of disease\n2. Prior locoregional therapy to target lesions is not allowed. History of curative locoregional therapy is allowed provided the following are met: 1) previously treated tumor is not viable without evidence of residual disease for at least 12 months, and 2) patient has not received local therapy in the past 12 months.\n3. Known fibrolamellar HCC or combined HCC-cholangiocarcinoma histology\n4. History of hepatic encephalopathy\n5. Severe ascites requiring paracentesis in the past 3 months\n6. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study\n7. Prior significant bleeding event in the past 3 months that may pose a surgical risk\n8. 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)\n9. Underlying medical conditions that, in the investigator's opinion, will make the administration of study drugs hazardous, including but not limited to:\n\n   1. Autoimmune interstitial lung disease (lymphangitic spread of cancer is not disqualifying or stable\u002Fchronic lung disease that is not likely to be autoimmune in nature and progressive),\n   2. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of study drugs,\n   3. Clinically significant cardiovascular disease,\n   4. A condition that may obscure the interpretation of toxicity determination or AEs,\n   5. History of prior bone marrow and\u002For solid-organ transplantation\n10. Hypersensitivity to IV contrast; not suitable for pre-medication\n11. Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past year (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), with the following exceptions:\n\n    1. Autoimmune diseases with only dermatologic involvement such as eczema, vitiligo, lichen chronicus, or resolved childhood asthma\u002Fatopy which involves less than 10% of the body surface area and symptoms are well controlled on topical treatments without recent exacerbations requiring other therapies\n    2. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n    3. Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study\n12. 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.\n13. 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. Patients with a cancer history with a low risk of recurrence or progression may be enrolled as determined by the principal investigator.\n14. Prisoners or subjects who are involuntarily incarcerated\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 (Human chorionic gonadotropin) laboratory test\n16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n17. Evidence of bleeding diathesis or significant coagulopathy\n18. Current use of full dose anticoagulant use which cannot be temporarily discontinued for surgery\n19. Receipt of live vaccinations within 30 days of first treatment day","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The goal of this clinical study is to find out if cadonilimab or ateganosine plus cadonilimab is effective and safe in treating resectable hepatocellular carcinoma (HCC).",[26],"Resectable Hepatocellular Carcinoma",[28,29],"liver","hepatocellular carcinoma","NOT_YET_RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":20},"2026-09-01",{"date":38,"type":20},"2031-08-01",{"name":40,"class":41},"University of Texas Southwestern Medical Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100493156","phase-1-sirt-with-tremelimumab-and-durvalumab-for-resectable-hcc-100493156","NCT05701488","SIRT With Tremelimumab and Durvalumab for Resectable HCC","A Phase 1 Neoadjuvant Trial of Selective Internal Yttrium-90 Radioembolization (SIRT) With Tremelimumab and Durvalumab (MEDI4736) for Resectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Histologically confirmed HCC (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects (presence of arterial hypervascularity with venous washout). For subjects without cirrhosis, histological confirmation is mandatory.\n* Participants must have resectable disease. Those patients must have preserved liver function (Child A) and with either AJCC stage IA, IB, II, and IIIA or BCLC stage 0 or stage A disease. The determination of resectability will ultimately lie in the clinical judgment of the treating investigator and surgical oncologist involved in the care of the patient.\n* Participants must be treatment naïve for HCC.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of tremelimumab, durvalumab, and SIRT in participants \\\u003C18 years of age, children are excluded from this study.\n* Measurable disease per RECIST 1.1 criteria.\n* ECOG performance status ≤ 1 (see Appendix A).\n* Body weight \\>30 kg.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Absolute Neutrophil Count (ANC) ≥ 1,000 \u002FmcL\n  * Platelets ≥ 80,000 \u002FmcL\n  * Total Bilirubin ≤ 2.0 mg\u002FdL\n  * AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN)\n  * Measured Creatinine Clearance \\> 40 mL\u002Fmin by 24-hour urine collection, or\n  * Calculated Creatinine Clearance (CL) \\> 40 mL\u002Fmin by the Cockcroft-Gault Formula (Cockcroft Gault 1976):\n\n    * Males: Creatinine CL (mL\u002Fmin) = (weight (kg) × (140 - Age)) \u002F (72 × serum creatinine (mg\u002FdL))\n    * Females: Creatinine CL (mL\u002Fmin) = (weight (kg) × (140 - Age) \u002F (72 × serum creatinine (mg\u002FdL))) × 0.85\n* Women of childbearing potential (WOCBP, refer to Section 5.4) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) obtained during the trial screening period.\n* Men and WOCBP must agree to follow the protocol instructions for acceptable method(s) of contraception for the duration of trial treatment and for a total of 5 months post-treatment completion. Refer to Section 5.4.\n* Participants 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 as assessed by the treating investigator are eligible for this trial.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have received any prior treatment for HCC.\n* Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to first dose of study drug.\n* History of allogenic organ transplantation.\n* Participants who are receiving any other investigational agents.\n* 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 sponsor-investigator\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab or tremelimumab.\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection (including tuberculosis), uncontrolled hypertension (defined as blood pressure of \\> 140\u002F90 mmHg during the screening period despite medical management), 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.\n* Patients who have a primary brain tumor (excluding meningiomas and other benign lesions), any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, or history of a stroke within the year prior to the first dose of study drug.\n* History of active primary immunodeficiency.\n* Known active infection of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n\n  --Patients positive for HIV are allowed on study, but HIV-positive patients must have:\n  * A stable regimen of highly active anti-retroviral therapy (HAART)\n  * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n  * A CD4 count above 250 cells\u002FmcL and an undetectable HIV viral load or standard PCR-based tests\n* Known active hepatitis B infection (known positive HBV surface antigen (HBsAg) result). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible.\n* Known active hepatitis C infection. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of study agent. 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 that do not exceed 10 mg\u002Fday of prednisone or its equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study drug and for at least 30 days after the last dose of study agent.\n* History of serious systemic disease, including myocardial infarction or unstable angina within the 12 months prior to the first dose of study drug, history of hypertensive crisis or hypertensive encephalopathy, New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), significant vascular disease or symptomatic peripheral vascular disease.\n* Participants who have a known clinical history of coagulopathy, bleeding diathesis, or thrombosis within the 12 months prior to the first dose of study drug.\n* Participants who have a serious, non-healing wound, ulcer, bone fracture or with history of pneumonitis or interstitial lung disease.\n* Participants who are pregnant or breastfeeding. A negative serum or urine pregnancy test obtained during the screening period is required for trial enrollment.\n* Participants requiring total parenteral nutrition with lipids.",{"count":51,"type":20},20,[53],"PHASE1","The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery.\n\nThe names of the interventions involved in this study are:\n\n* Durvalumab (a type of immunotherapy)\n* Tremelimumab (a type of immunotherapy)\n* Selective Internal Yttrium-90 Radioembolization (SIRT) (a type of radiation microsphere bead)",[26,56,57],"Hepatocellular Carcinoma","Hepatocellular Cancer",[26,56,57,59],"Liver Cancer","RECRUITING","2025-08-26",{"date":63,"type":34},"2025-09-02",{"date":65,"type":34},"2023-04-21",{"date":67,"type":20},"2026-10-01",{"name":69,"class":41},"Jiping Wang, MD, PhD",3,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100594400","phase-2-study-to-evaluate-the-efficacy-and-safety-of-atezolizumab-and-bevacizumab-as-neoadjuvant-plus-adjuvant-treatment-in-hcc-100594400","NCT07018947","Study to Evaluate the Efficacy and Safety of Atezolizumab and Bevacizumab as Neoadjuvant Plus Adjuvant Treatment in HCC","A Phase II, Randomized, Open-label, National, Multicenter Study Evaluating the Efficacy and Safety of the Combination of Atezolizumab and Bevacizumab as Neoadjuvant Plus Adjuvant Treatment in Hepatocellular Carcinoma (ASPIRE)","ASPIRE","Inclusion Criteria:\n\n1. Signed Informed Consent Form.\n2. Age ≥ 18 years at the time of signing Informed Consent Form.\n3. Ability to fully comply with the protocol, in the investigator's judgment.\n4. Diagnosis of HCC confirmed by histology.\n5. HCC that is amenable to R0 surgical resection with curative intent in the opinion of the surgeons and oncologists or hepatologists involved in the care of the participant.\n6. HCC at high-risk of recurrence defined by either multifocality, large tumor diameter (\\>5cm), AFP (alpha-fetoprotein) ≥400ng\u002FmL, poor tumor differentiation, or the presence of microvascular invasion.\n\n   \\- For patients with tumors between 3-5 cm, a predefined nomogram will be applied, indicating a high prevalence of microvascular invasion with a score \\>200 points. (Lie et al., 2016).\n7. Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0.\n9. Child-Pugh Class A.\n10. No evidence of clinically significant portal hypertension (CSPH) or minor CSPH (HVPG \\\u003C12 mmHg) in candidates for minor resection (fewer than 3 segments). (Galle et al., 2018) Clinically significant portal hypertension (CSPH) can be defined either by its gold standard measurement, a hepatic venous pressure gradient (HVPG) ≥10 mmHg, or by the presence of surrogate markers such as a platelet count \\\u003C100,000 × 10³\u002FµL combined with splenomegaly.\n11. Willing to undergo a tumor biopsy at screening visit.\n\n    \\- Baseline tumor tissue samples will be collected from all participants by means of a core-needle biopsy performed at study entry. A minimum of two core-needle biopsies are required. If a fresh biopsy is not deemed feasible by the investigator, archival tumor tissue may be submitted, provided the tissue was obtained from a biopsy performed within 3 months prior to enrollment and the patient has not received any anti-cancer therapy, including locoregional liver-directed therapy, since the time of the biopsy. Tumor and normal adjacent tissue specimen will be collected at surgery as fresh snap-frozen and formalin-fixed, paraffin-embedded (FFPE) format. FFPE tissue blocks are preferred, or a minimum of 20 slides must be submitted.\n12. No prior locoregional or systemic treatment for HCC.\n13. Adequate hematologic and end-organ function, defined by the following laboratory test results:\n\n    * ANC ≥ 1.5 × 109\u002FL (1500\u002FµL) without granulocyte colony-stimulating factor (G-CSF) support.\n    * Lymphocyte count ≥ 0.5 × 109\u002FL (500\u002FµL).\n    * Platelet count ≥ 75 × 109\u002FL (75,000\u002FµL) without transfusion.\n    * Hemoglobin ≥ 90 g\u002FL (9.0 g\u002FdL) without transfusion. Participants must not have required transfusion during screening or within 2 weeks prior to screening to meet this criterion.\n    * AST, ALT, and ALP ≤ 5 × upper limit of normal (ULN).\n    * Bilirubin ≤ 3 × ULN.\n    * Adequate renal function: creatinine clearance by estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease Study (MDRD) formula ≥ 50 mL\u002Fmin. Participants with creatinine clearance by estimating eGFR by MDRD formula of ≥ 30 mL\u002Fmin and ≤ 50 mL\u002Fmin may be enrolled if renal function was stable for ≥ 28 days prior to randomization.\n    * Albumin ≥ 28 g\u002FL (2.8 g\u002FdL) without transfusion.\n    * For participants not receiving anticoagulation: INR or aPTT ≤ 1.5 × ULN.\n14. Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV):\n\n    * Patients with active HBV must have HBV DNA \\\u003C 500 IU\u002FmL during screening, must have initiated anti-HBV treatment at least 14 days prior treatment initiation, and must be willing to continue anti-HBV treatment during the study (per local standard of care, e.g., entecavir).\n    * Patients with HCV, either with resolved infection (as evidenced by detectable antibody) or chronic infection (as evidenced by detectable HCV RNA), are eligible.\n    * For patients with detectable HCV RNA and for whom HCV treatment is considered appropriate by the investigator, treatment should begin no sooner than 6 months following liver resection consistent with AASLD guidelines.\n15. Negative HIV test at screening with the following exception:\n\n    \\- Individuals with a positive HIV test at screening are eligible if they are stable on anti-retroviral therapy, have a CD4 count ≥ 200\u002FmL, and have an undetectable viral load.\n16. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.\n17. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm.\n\nExclusion Criteria:\n\n1. Presence of extrahepatic disease or macrovascular invasion.\n2. Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or other rare variants of HCC.\n3. History of hepatic encephalopathy if clinically significant within one year prior to screening.\n4. CSPH in candidates for major resection (more than 3 segments).\n5. Moderate or severe ascites.\n6. Active co-infection with HBV and HCV (defined as detectable HCV RNA plus positive HBV surface antigen or HBV DNA). Patients with a history of HCV infection but who are negative for HCV RNA by Polymerase Chain Reaction (PCR) will be considered non-infected with HCV.\n7. Known active co-infection with HBV and hepatitis D viral infection (HDV).\n8. Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.\n9. Treatment with investigational therapy within 28 days prior to screening.\n10. Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or that are at high risk for bleeding. Participants must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed and treated per local standard of care prior to enrollment. Participants who have undergone an EGD within 6 months prior screening do not need to repeat the procedure.\n11. A prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to screening.\n12. Inadequately controlled hypertension, defined as systolic blood pressure (BP) \\> 150 mmHg and\u002For diastolic BP \\> 100 mmHg (average of at least three readings at two or more sessions).\n\n    \\- Anti-hypertensive therapy to achieve these parameters is allowed.\n13. History of hypertensive crisis or hypertensive encephalopathy.\n14. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to screening.\n15. History of hemoptysis (≥ 2.5 mL of bright red blood per episode) within 1 month prior to screening.\n16. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).\n17. Current or recent (≤ 10 days prior to screening) use of aspirin (\\> 325 mg\u002Fday) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol.\n\n    \\- Chronic use of low dose aspirin (\\\u003C 325 mg\u002Fday) for cardioprotection is allowed.\n18. Current or recent (≤ 10 days prior to screening) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose.\n\n    * Prophylactic anticoagulation for the patency of venous access devices is allowed provided the activity of the agent results in an INR \\\u003C 1.5 × ULN and aPTT is within normal limits within 14 days prior to screening.\n    * Prophylactic use of low-molecular-weight heparin (LMWH; i.e., enoxaparin 40 mg\u002Fday) is allowed. However, the use of direct oral anticoagulant therapies such as dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) are not recommended due to potential bleeding risk. Benefits and risks should be assessed, and caution exercised for use of direct oral anticoagulants.\n\n    The investigator should consider switching to other approved anticoagulants due to the risk of upper GI (gastrointestinal) bleeding in patients with HCC.\n\n    \\- For prophylactic use of anticoagulants or thrombolytic therapies, the approved dose as described on the local label may be used.\n19. History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to screening.\n20. History of intestinal obstruction and\u002For clinical signs or symptoms of GI obstruction, including subocclusive or occlusive syndrome related to the underlying disease, or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding prior to screening.\n21. Evidence of abdominal free air that is not explained by paracentesis or recent (\\\u003C 3 months) abdominal surgical procedure.\n22. Serious, non-healing, or dehiscing wound, active ulcer, or untreated bone fracture.\n23. Grade ≥ 2 proteinuria, as demonstrated by ≥ 2+ protein on dipstick urinalysis and ≥ 1.0 g of protein in a 24-hour urine collection.\n\n    * All patients with ≥ 2+ protein on dipstick urinalysis at screening must undergo a 24-hour urine collection (or an alternative method such as protein\u002Fcreatinine ratio, per local guidance) for protein and must demonstrate \\\u003C 1 g of protein in 24 hours.\n    * Patients with \\\u003C 2+ protein on dipstick urinalysis are eligible for the study.\n24. History of intra-abdominal inflammatory process within 6 months prior to screening, including but not limited to peptic ulcer disease, diverticulitis, or colitis.\n25. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to screening; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to screening; or anticipation of need for major surgical procedure, other than potentially curative liver resection, during the study; or non-recovery from side effects of any such procedure.\n26. Complete healing from minor surgery (e.g., simple excision, tooth extraction) must have occurred at least 7 days before screening.\n27. Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID).\n\n    \\- The occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed.\n28. Serious infection requiring oral or IV antibiotics and\u002For hospitalization within 4 weeks prior to screening, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact participant safety.\n29. Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study.\n30. History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n\n    * Patients with localized prostate cancer (defined as Stage ≤ pT2c, Gleason score ≤ 7, and prostate-specific antigen (PSA) at prostate cancer diagnosis ≤ 20 ng\u002FmL) treated with curative intent and without PSA recurrence are eligible.\n    * Patients with pre-existing low-risk prostate cancer (defined as Stage cT1\u002FT2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n    * Patients with malignancies associated with a negligible risk of metastasis or death (e.g., risk of metastasis or death \\\u003C 5% at 5 years) are eligible provided they meet all of the following criteria:\n\n      * Malignancy treated with expected curative intent (e.g., adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent)\n      * No evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.\n31. Active or history of autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n    * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n    * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n    * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n      * Rash must cover \\\u003C 10% of body surface area.\n      * Disease is well controlled at baseline and requires only low-potency topical corticosteroids.\n      * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.\n32. Pregnancy or breastfeeding, or intention of becoming pregnant during the study.\n\n    \\- Female participants of childbearing potential must have a negative serum pregnancy test result at screening.\n33. Left ventricular ejection fraction (LVEF) \\\u003C 50% assessed by either transthoracic echocardiogram (TTE) or multiple-gated acquisition (MUGA) scan (TTE preferred test) within 6 months prior to screening.\n34. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n35. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\n    \\- History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n36. Prior allogeneic stem cell or solid organ transplantation.\n37. Active tuberculosis.",{"count":80,"type":20},90,[82],"PHASE2","Study to evaluate the efficacy and safety of the combination of Atezolizumab and Bevacizumab as neoadjuvant plus adjuvant treatment in Hepatocellular Carcinoma.",[26],[86],"resectable HCC with high risk of recurrence","2025-06-05",{"date":89,"type":34},"2025-06-13",{"date":91,"type":20},"2025-11",{"date":93,"type":20},"2030-11",{"name":95,"class":41},"Fundacion Clinic per a la Recerca Biomédica",13,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":106,"targetDuration":107,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100559850","neoadjuvant-triple-therapy-for-resectable-hcc-100559850","NCT06569498","Neoadjuvant Triple Therapy for Resectable HCC","Neoadjuvant Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Cadonilimab for Resectable Hepatocellular Carcinoma: A Single-Arm Phase II Clinical Trial","TALENP001","Inclusion Criteria:\n\n1. Voluntarily join the study and sign the informed consent form.\n2. Male or female patients aged between 18 and 75 years.\n3. Child-Pugh class A.\n4. Indocyanine green 15-minute retention rate (ICGR-15) \\\u003C 15%.\n5. ECOG performance status 0-1.\n6. Diagnosed with hepatocellular carcinoma (HCC) according to the \"Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition).\"\n7. BCLC stage A or B, with a single tumor larger than 5 cm or multiple tumors, and considered surgically resectable after multidisciplinary discussion.\n8. According to RECIST 1.1 criteria, the patient has at least one measurable lesion (a measurable lesion with a long diameter ≥ 10 mm on CT\u002FMRI scan, and the measurable lesion has not received local treatments such as radiotherapy or cryotherapy).\n9. Blood routine: absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, Hb ≥ 8.5 g\u002FL, PLT ≥ 75 × 10\\^9\u002FL.\n10. No history of severe arrhythmia, heart failure, severe pulmonary ventilation disorders, or severe lung infections; no acute or chronic renal failure, and creatinine clearance rate \\> 40 mL\u002Fmin.\n11. Women of childbearing potential must agree to use contraception during the medication period and for 6 months after the end of medication; have a negative serum or urine pregnancy test within 7 days prior to enrollment, and must not be breastfeeding. Men must agree to use contraception during the study period and for 6 months after the end of the study.\n\nExclusion Criteria:\n\n1. Tumor rupture with bleeding or suspected abdominal cavity metastasis.\n2. Previous treatment with any antitumor therapies before enrollment, such as targeted drugs, PD-1\u002FPD-L1\u002FCTLA-4 monoclonal antibodies, surgery, TACE, FOLFOX systemic chemotherapy, radiotherapy, and Huaier granules.\n3. History of allergy to lenvatinib, cadonilimab, or their components.\n4. Presence of any active autoimmune disease or a history of autoimmune disease with expected recurrence (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes mellitus treated with stable doses of insulin; excluding patients with vitiligo or childhood asthma\u002Fallergies that have resolved and require no intervention in adulthood.\n5. History of immunodeficiency; patients using immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes and who have continued using them within 2 weeks before signing the informed consent form.\n6. Known hereditary or acquired bleeding (e.g., coagulopathy) or thrombotic tendency, such as hemophilia; currently receiving or recently (within 10 days before the start of study treatment) receiving full-dose oral or injectable anticoagulants or thrombolytics for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed).\n7. Severe infection within 4 weeks before the first use of the study drug (CTC AE grade \\> 2), such as severe pneumonia requiring hospitalization, bacteremia, or infection complications; baseline chest imaging indicating active lung inflammation; symptoms and signs of infection within 2 weeks before the first use of the study drug or requiring oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use).\n8. Urinalysis indicating proteinuria ≥ 1+; if so, a 24-hour urine protein test is required; patients with 24-hour urine protein ≥ 1 g.\n9. History of other malignancies within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma.\n10. Patients with concomitant psychiatric disorders; history of substance abuse, alcohol, or drug addiction.\n11. Pregnant or breastfeeding women.\n12. Patients with significant surgical contraindications, such as renal and cardiopulmonary insufficiency, as judged by the investigator, or any other reasons deemed unsuitable for participation in this trial by the investigator.","75 Years",{"count":51,"type":20},"3 Years","OBSERVATIONAL","This study is a single-arm, multi-center, prospective phase II trial aimed at evaluating the efficacy and safety of neoadjuvant therapy with transarterial chemoembolization (TACE) combined with lenvatinib and camrelizumab (triple therapy) in patients with resectable hepatocellular carcinoma (HCC). The study plans to enroll 20 patients. The primary endpoints are major pathological response (MPR) rate and safety, while the secondary endpoints are recurrence-free survival (RFS), objective response rate (ORR), R0 resection rate, and overall survival (OS).",[26],"2024-10-11",{"date":113,"type":34},"2024-10-15",{"date":115,"type":34},"2024-09-30",{"date":117,"type":20},"2026-12-01",{"name":119,"class":41},"Fujian Provincial Hospital",6]