[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatocellular-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatocellular-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,43,76,113,140,181,208,236,254,284,308,335,356,380,406,433,463],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100601418","yttrium-90-radiation-segmentectomy-for-hepatocellular-carcinoma-100601418",false,"NCT07110233","Yttrium-90 Radiation Segmentectomy for Hepatocellular Carcinoma","Prospective Phase 2 Trial of Yttrium-90 Radiation Segmentectomy for Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Participants must have histologically or imaging-confirmed confirmed HCC.\n2. Group 1: Solitary tumor measuring 2-5 cm Or Group 2: 2-3 tumors each ≤ 3 cm in diameter.\n3. No prior therapy to target tumor(s).\n4. Not a candidate for surgical resection or thermal ablation after multidisciplinary assessment.\n5. Age ≥22 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1.\n7. Demonstrated adequate organ function as defined below:\n\n   1. Total bilirubin ≤3.0 mg\u002FdL, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.\n   2. aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) ≤5 X institutional upper limit of normal.\n   3. alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) ≤5 X institutional upper limit of normal.\n   4. Creatinine Glomerular filtration rate (GFR) \\> 30 ml\u002Fmin.\n8. Child-Pugh score ≤ B7\n9. Albumin-bilirubin (ALBI) score 1-2\n10. Participants who have received systemic therapy for HCC will be excluded from the trial.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n12. Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n13. 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 are eligible for this trial.\n\nExclusion Criteria:\n\n1. Macrovascular tumor invasion or infiltrative appearance of hepatocellular carcinoma.\n2. History of severe allergy to iodinated contrast agents despite appropriate premedication.\n3. Is currently receiving any other anti-cancer agents and any previous therapy with a device that uses Y90 as the radioisotope.\n4. Symptomatic heart failure or severe valvular insufficiency.\n5. Symptomatic pulmonary hypertension or lung disease.\n6. Symptomatic ascites.\n7. Severe uncontrolled coagulopathy International Normalized Ratio (INR) ≥ 3.0 or Platelet ≤ 20,000.\n8. Main vein thrombosis (portal vein, both bland and tumor thrombus). Note: Less than lobar portal vein thrombosis is allowable only if the thrombus is bland.\n9. Pregnant women are excluded from this study because TheraSphere emits radiation with 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 TheraSphere, breastfeeding should be discontinued if the mother is treated with TheraSphere.\n10. Lung-shunt fraction (LSF) resulting in anticipated lung dose of \\>30 Gray (Gy).\n11. History of sphincterotomy, biliary-enteric anastomosis, or other biliary tract instrumentation. Note: Prior cholecystectomy with or without bile duct exploration is permitted.\n12. Tumor perfused by extrahepatic collateral arteries.\n13. Prior partial hepatectomy.\n14. Psychiatric illness, other significant medical illness, or social situation which, in the investigator's opinion, would limit compliance or ability to comply with study requirements.\n15. History of or current extrahepatic cancer.\n16. Pulmonary insufficiency (defined by an arterial oxygen pressure (Pa,O2) of \\\u003C 60 mmHg, or oxygen saturation (Sa,O2) of \\\u003C 90%).","ALL","22 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a prospective, single-blinded, single-arm, open-label Phase II trial of trans-arterial radiation segmentectomy using Yttrium-90 glass microspheres (TheraSphere®) for Hepatocellular Carcinoma (HCC) participants with unresectable Barcelona clinic liver cancer (BCLC) stage A disease.",[26,27,28,29],"Hepatocellular Carcinoma","Unresectable Hepatocellular Carcinoma","Hepatocellular Cancer","Hepatocellular Carcinoma Non-resectable","NOT_YET_RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-26","ACTUAL",{"date":36,"type":20},"2026-10-01",{"date":38,"type":20},"2029-03-31",{"name":40,"class":41},"University of California, San Francisco","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"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.","18 Years",{"count":52,"type":20},138,[54,55],"PHASE1","PHASE2","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.",[58,28,26,27,59,60,61],"Carcinoma, Hepatocellular","Liver Neoplasms","Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma",[26,63,59],"Liver cancer","RECRUITING","2026-06-03",{"date":67,"type":34},"2026-06-04",{"date":69,"type":34},"2025-12-01",{"date":71,"type":20},"2028-10-17",{"name":73,"class":74},"Pfizer","INDUSTRY",35,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100534466","phase-1-dose-escalation-and-dose-expansion-study-of-mdx2001-in-patients-with-advanced-solid-tumors-100534466","NCT06239194","Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors","A Phase 1\u002F2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age\n* Histologically or cytologically confirmed diagnosis of metastatic solid tumors\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.\n* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Adequate hematologic, hepatic and renal function\n* Capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Any clinically significant cardiac disease\n* Unresolved toxicities from previous anticancer therapy\n* Prior solid organ or hematologic transplant\n* Known untreated, active, or uncontrolled brain metastases\n* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectiion requiring intravenous treatment.\n* Receipt of a live-virus vaccination within 28 days of planned treatment start\n* Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.\n* Participation in a concurrent clinical study in the treatment period.\n* Known hypersensitivity to MDX2001 or any of its ingredients\n* Supplemental oxygen use for activities of daily living\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",{"count":84,"type":20},285,[54,55],"This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.",[88,89,90,91,92,93,94,95,96,28,97,98,99,100,101,102],"Biliary Tract Cancer","Breast Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gastric Cancer","GastroEsophageal Cancer","Head and Neck Cancer","Non-small Cell Lung Cancer","Pancreatic Cancer","Prostate Cancer","Rectal Cancer","Renal Cancer","Thyroid Cancer","2026-05-03",{"date":105,"type":34},"2026-05-06",{"date":107,"type":34},"2024-06-12",{"date":109,"type":20},"2029-02",{"name":111,"class":74},"ModeX Therapeutics, An OPKO Health Company",6,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":42},"100273409","tumor-cell-and-dna-detection-in-the-blood-urine-and-bone-marrow-of-patients-with-solid-cancers-100273409","NCT02838836","Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers","Inclusion Criteria:\n\n* Subjects older than 18 years.\n* Subjects of all genders and ethnicities.\n* Subjects with the diagnosis of a solid cancer (n=100) of all stages will be included (lung, esophageal, stomach, bile duct\u002Fpancreas, colorectal, melanoma, sarcoma).\n* Ten patients with no present suspicion and no previous history of any cancer (except basal cell cancer of the skin) that undergo surgeries for other benign indications will serve as controls (n=20).\n* In patients undergoing surgery for cancer the histopathology should preferably be pathologically proven by a previous or novel biopsy. Yet, patients with a high cancer suspicion by radiology and clinical picture that undergo cancer surgery will not be excluded. No additional biopsies, testing or interventions will be performed for the purpose of this study if the medical treatment will not require it.\n* Subjects must be capable of giving informed consent.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Subjects with the concurrent diagnosis of an active secondary (synchronous) malignancy besides basal cell carcinoma of the skin will be excluded, if there is evidence of disease burden or if the patient is currently being treated with chemotherapy.\n* Subjects with a hemoglobin of \\\u003C8g\u002Fdl in the morning of the procedure will be excluded.\n* In subjects who require intraoperative transfusions of \\>4 units of red packed blood cells (RPBCs), no further blood will be drawn for CTC\u002FDTC\u002FcfDNA analysis during surgery or on postoperative day 1.\n* In patients with coagulation disorders that could lead to significant bleeding (such as hemophilia, significant thrombocytopenia) requiring prophylactic administration of coagulative products, no bone marrow aspiration will be performed.",true,{"count":121,"type":20},620,"OBSERVATIONAL","Patients with resectable solid primary cancers and even limited number of metastases are potentially curable. However, most patients develop recurrences despite surgery. Circulating and disseminated tumor cell (CTC\u002FDTC) and circulating cell-free (cf) DNA isolation from the blood, urine and bone marrow will increase understanding of cancer spread and advance knowledge to develop individualized therapies.",[97,93,94,98,28,125],"Colorectal Cancer",[127,128,129,130],"Cancer","Circulating tumor cells (CTCs)","Disseminated tumor cells (DTCs)","Circulating tumor DNA (ctDNA)","2026-04-27",{"date":133,"type":34},"2026-05-01",{"date":135,"type":34},"2016-07-01",{"date":137,"type":20},"2027-12-01",{"name":139,"class":41},"University of Missouri-Columbia",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":167,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100543937","phase-1-a-study-of-oral-7hp349-alintegimod-in-combination-with-ipilimumab-followed-by-nivolumab-monotherapy-100543937","NCT06362369","A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy","A Phase 1b\u002F2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Locally Advanced or Metastatic Cancers Following One or More Prior Therapies","Inclusion and Exclusion Criteria for Phase 1b\n\nInclusion Criteria\n\n1. Adult patients (age 18 or older)\n2. Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, or tumor types for which the combination of ipilimumab and nivolumab has been FDA approved. Patients may have received treatment with anti PD-1\u002FPD-L1.\n3. ANC ≥ 1000\u002FµL without use of G-CSF, Hgb ≥ 9 g\u002FdL without required blood transfusion for at least 5 days prior to pretreatment baseline, and platelet count ≥ 75,000\u002FµL without transfusions for at least 5 days prior to pretreatment baseline.\n4. ECOG performance status of 0 or 1.\n5. Has a life expectancy of \\> 12 weeks.\n6. Renal and hepatic function requirements:\n\n   * a. Renal function with either an eCrCL ≥ 60 mL\u002Fmin (modified Cockcroft-Gault) or eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2 (using MDRD or CKD-EPI or similar equations).\n   * b. Hepatic function with ALT\u002FAST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert Syndrome). If patients have hepatic metastases, then AST\u002FALT≤ 5 x ULN will be allowed.\n7. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n8. All Grade 3 AEs related to prior therapies have returned to Grade 1 or resolved to baseline (this includes with appropriate therapy in the case of thyroid dysfunction).\n9. All patients must have measurable disease by applicable RECIST criteria.\n10. Willing to allow blood samples to be used for research.\n\nExclusion Criteria:\n\n1. Patients must not have received prior anticancer therapy or radiation therapy within the 3 weeks and must not have undergone major surgery within 4 weeks prior to initiation of treatment on protocol. Palliative radiation therapy is allowed. For small molecules (MW \\\u003C 0.9 kDA), the washout period is 3 weeks or 5 half-lives, whatever comes first.\n2. Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by MRI brain imaging for at least 4 weeks, and the patient must have been off steroids for at least 2 weeks prior to first dose of study drug.\n3. Previous episodes of ≥ Grade 3 (G3) immune-related toxicity that includes G3 colitis, G3 pneumonitis, G3 skin rash, G3 increase in liver enzymes (with the exception of symptoms that in the opinion of the investigator will not compromise the patients' safety on the trial. Patients with stable endocrinological AEs (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus) are allowed.\n4. Persistent toxicity of NCI CTCAE version 5 Grade \\> 1 severity that is related to prior therapy.\n\n   Note: Sensory neuropathy, hypothyroidism or alopecia of Grade ≤ 2 are acceptable. Other Grade 2 toxicities of prior treatments that are controlled with medication (e.g., diabetes or hypertension) are permitted.\n5. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome p450 3A (CYP3A) within 2 weeks before study intervention. Alintegimod may increase exposure to CYP3A4 substrates; consider a dose reduction of such substrates and monitor for signs of toxicities of co-administered sensitive CYP3A substrates (see listing of strong inhibitors and inducer drugs in FDA tables). An alternative is to replace such agents with drugs that are not CYP3A4 metabolized if at all feasible.\n6. The patient has cardiac conditions as follows:\n\n   * a) myocarditis;\n   * b) uncontrolled hypertension (blood pressure \\> 160\u002F100) despite optimal therapy;\n   * c) uncontrolled angina; ventricular arrhythmias; congestive heart failure (New York Heart Association Class II or above);\n   * d) prior or current cardiomyopathy;\n   * e) 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   * f) concomitant medication with drugs known to cause Torsades de Pointes;87\n   * g) QT interval correction for heart rate using Fridericia's formula (QTcF) ≥ 470 ms (average from 3 QTcF values on the triplicate 12-lead electrocardiogram \\[ECG\\]) at screening.\n7. Known history of a positive test for HIV, or positive test for hepatitis B (positive for HBsAg) or hepatitis C (HCV RNA).\n8. Concurrent malignancies are permitted if 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 with agreement from the Principal Investigator (PI), patients 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 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.\n9. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WOCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WOCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n10. 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).\n11. Use of corticosteroids or other immunosuppressive medication, current or within 14 days of administration of Alintegimod with the following exceptions:\n\n    * a) Topical, intranasal, inhaled, ocular, intra-articular corticosteroids;\n    * b) Physiological doses of replacement corticosteroids (e.g., for adrenal insufficiency) are not to exceed 10 mg\u002Fday of prednisone or equivalent.\n    * c) Corticosteroid premedication for infusion and\u002For hypersensitivity reactions.\n    * d) Patients may be treated with a short (\\\u003C24h) pulse course of corticosteroids to mitigate infusion or hypersensitivity reactions to radiocontrast agents.\n12. Receipt of live attenuated vaccine within 28 days of the first dose of Alintegimod.\n13. Serious autoimmune disease at the discretion of the treating Investigator: 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 participation in this study\n14. Active or history of pneumonitis (drug-induced), idiopathic pulmonary fibrosis, Interstitial Lung Disease (ILD), or lung disease that may interfere with assessment of pneumonitis. History of radiation pneumonitis in a previous radiation field is permitted.\n15. Previous participation in a study of any investigational agent within 21 days of enrollment or within 5 half-lives of the study treatment, whichever is the least.\n16. Use of mechanical ventilation or having a resting O2 saturation \\\u003C 90% (on room air) by pulse-oximetry, require renal dialysis, require vasopressors, and\u002For severe hepatic sinusoidal obstruction syndrome.\n17. Proven or suspected ongoing systemic infection requiring IV antibiotics.\n18. Women who are pregnant or lactating.\n\n    Note: Women of childbearing potential (WOCBP) must have a \"negative\" serum pregnancy test within 1 week prior to treatment. Non-childbearing potential is defined as 1 of the following:\n    * a) Postmenopausal with \\> 1 year since last menses and:\n    * 1\\. If ≥ 65 years old, follicle-stimulating hormone (FSH) \\> 40 mIU\u002FmL.\n    * 2\\. If ≥ 65 years old and not on hormone replacement therapy (HRT), FSH \\> 30 mIU\u002FmL.\n    * 3\\. If ≥ 65 years old and on HRT, the FSH requirement is not applicable. Postmenopausal females on HRT will be allowed if HRT has been stable for ≥ 6 months prior to dosing of study drug(s).\n    * b) Written medical documentation of being sterilized (e.g., hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed ≥ 6 months prior to dosing study drug(s).\n\n    Note: Tubal ligation is not considered a form of permanent sterilization.\n19. Psychiatric illness\u002Fsocial circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events or have compromised ability to provide written informed consent.\n20. Patients who have had allogeneic tissue or solid organ transplantation. Prior T cell therapy is allowed\n21. Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg (NIH-ODS 2022; Section 5.9.2.1).\n\n    Note: Patients who switch from a high dose to a dose of ≤30 µg\u002Fday are eligible for study entry.\n22. Any condition that is in the opinion of the investigator may compromise patient's participation in the trial.\n23. Active peptic ulcer disease or gastritis, active diverticulitis, or other serious gastrointestinal disease associated with diarrhea within the past 2 years before the start of therapy or GI disease which affects oral drug absorption.\n24. Patients with known soy allergy.",{"count":148,"type":20},126,[54,55],"This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.\n\nCurrently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b",[152,153,154,155,156,157,158,159,125,26,28,160,161,162,163,164,165,166],"Advanced Cancer","Advanced Solid Tumor","Melanoma","Metastasis","Pleural Mesothelioma","Renal Cell Carcinoma","MSI-High","Mismatch Repair Deficiency","Renal Cell Cancer","Kidney Cancer","Skin Cancer","Non Small Cell Lung Cancer","NSCLC","Anaplastic Lymphoma Kinase Genomic Tumor Aberrations","ALK Genomic Tumor Aberrations",[168,169,170],"Phase 1","Phase 1b","7 Hills Pharma","2026-04-07",{"date":173,"type":34},"2026-04-13",{"date":175,"type":34},"2024-08-23",{"date":177,"type":20},"2028-12-31",{"name":179,"class":74},"7 Hills Pharma, LLC",5,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":42},"100439561","phase-1-gpc3-targeted-car-t-cell-therapy-in-advanced-gpc3-expressing-solid-tumor-malignancies-100439561","NCT05003895","GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Solid Tumor Malignancies","Phase I Study of GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Solid Tumor Malignancies","* INCLUSION CRITERIA:\n* Histopathological confirmation of HCC or other solid tumor malignancy by the NCI Laboratory of Pathology\n* Participants must:\n\n  * have progressed on at least 1 prior line of treatment\n\nOR\n\n--been intolerant of at least 1 prior line of treatment.\n\n* Participants must have at least 1 focus of disease that is amenable to mandatory tumor biopsy prior to study treatment initiation to determine tumor GPC3 expression and be willing to undergo this. Ideally, the biopsied lesion should not be one of the target measurable lesions, although this can be up to the discretion of the investigators.\n* Tumor must have GPC3 positivity of \\>= 25% by immunohistochemistry on freshly collected biopsy\n* Participants must have at least 1 measurable lesion by RECIST version 1.1\n* Participants must have a disease that is not amenable to potentially curative resection, ablation, or transplantation.\n* Age \\>= 18 years.\n* Performance status (ECOG) 0-1\n* Participants must have adequate organ and marrow function as defined below:\n\nANC: \\>= 1,000\u002FmcL\n\nPlatelets: \\>= 75,000\u002FmcL\n\nHemoglobin: \\>= 8 g\u002FdL\n\ntotal bilirubin: If cirrhosis present: Part of Child Pugh requirement\n\nIf no cirrhosis: bilirubin should be \\\u003C= 1.5 x ULN\n\nALT or AST: \\\u003C= 5 x ULN.\n\nCreatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl) (A): \\\u003C 1.5x institution upper limit of normal OR \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 for participant with creatinine levels, \\>= 1.5 X institutional ULN\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase);\n\nAST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\n(A)Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n\n* Normal cardiac ejection fraction (\\>= 50% by echocardiogram) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram within 4 weeks before treatment initiation.\n* Room air oxygen saturation of 92% or greater.\n* Treatment-related toxicities must be resolved to \\\u003C= grade 1.\n* For participants with brain metastases: Participants with \\\u003C=3 (three or fewer) brain metastases that have been treated with surgery or stereotactic radiosurgery or other form of treatment are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment.\n* The study drugs are harmful to developing human fetus. For this reason, women of childbearing potential must agree to use highly effective contraception (hormonal, intrauterine device (IUD), abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy. Men must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 4 months after the last dose of study drugs. We also recommend men with partners of childbearing potential ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Men must not freeze or donate sperm within the same period.\n* HBV infected participants must be on antivirals and have HBV DNA \\\u003C 100IU\u002FmL. HCV infected participants can be enrolled with close HCV RNA level monitoring.\n* Participants must be able to understand and be willing to sign a written informed consent.\n* For participants that do not have a legally authorized representative in place, one must be identified before study treatment starts\n\nExclusion Criteria\n\n* Prior systemic therapy, an investigational therapy, radiation, and\u002For surgery within 2 weeks prior to treatment initiation.\n* Prior administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the PI can stimulate immune activity and interfere with an infusion of CAR-T cells within 8 weeks prior to treatment initiation.\n* Child-Pugh class B or C liver function\n* Uncontrolled intercurrent 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\nNote: Participants with a history of abnormal pulmonary function tests but stable obstructive or restrictive pulmonary disease may be eligible per PI discretion.\n\n* Any form of primary immunodeficiency (e.g. severe combined immunodeficiency).\n* HIV-positive participants are excluded because HIV causes complicated immune deficiency and study treatment can pose more risks for these participants.\n* Participants receiving systemic steroids \\>= 0.5 mg prednisone equivalent\u002Fkg\u002Fday. Steroid creams, ointments, and eye drops are allowed. Dose adjustment or discontinuation of medication must occur at least 24 hours prior to conditioning chemotherapy. Use of CART cell therapy in autoimmune diseases has the potential to be associated with serious safety risk. Given that this is an evolving area of research, caution should be exercised and any decision to include participants with autoimmune diseases should be made on a case-bycase basis.\n* History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.\n* Hospitalization within 7 days prior to treatment initiation.\n* Pregnant women are excluded from this study because study therapy can cause fetal harm. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with study therapy, breastfeeding should be discontinued if the mother is treated with study drugs.\n* Participants who received live or attenuated vaccine or virus-based vaccine within 30 days before initiation of study therapy\n* Participants with a history of seizure disorder\n* Participants with an expected life expectancy of less than 3 months before initiation of study therapy.","120 Years",{"count":190,"type":20},38,[54],"Background:\n\nA new cancer treatment takes a person s own T cells, modifies them in a laboratory so they can better fight cancer cells, and then gives them back to the person. Researchers want to see if this treatment can help people with a certain types of cancer.\n\nObjective:\n\nTo see if a personalized immune treatment, anti-GPC3 CAR-T cells, is safe.\n\nEligibility:\n\nAdults aged 18 years and older who have Glypican-3 (GPC3) positive solid tumor malignancy.\n\nDesign:\n\nParticipants will be screened with the following:\n\nBlood and urine tests\n\nMedical history\n\nPhysical exam\n\nHeart function tests\n\nReview of their symptoms and their ability to perform their normal activities\n\nTumor biopsy\n\nImaging scan of the chest, abdomen, and pelvis\n\nParticipants will have leukapheresis. They may have an IV (intravenous catheter, a small tube put into an arm vein) inserted into each arm or get a central line. Blood will be removed. A machine will separate the white blood cells from their blood. The rest of their blood will be returned to them.\n\nParticipants will be admitted to the hospital for about 2 weeks. They will get the chemotherapy drugs fludarabine and cyclophosphamide by IV for 3 days. Then they will receive the modified white blood cells by IV.\n\nParticipants will have frequent blood draws. They will give blood and tumor samples for research.\n\nParticipants will have follow-up visits for the next 15 years. Then they will be contacted by email or phone for the rest of their life. If their disease does not get worse after 5 years, they will continue to be invited to do imaging studies every 6 months.",[26,28,61],[195,196,197,198],"immuno therapy","Targeted Therapy","Leukapheresis","Gene Therapy","2026-04-04",{"date":171,"type":34},{"date":202,"type":34},"2021-12-08",{"date":204,"type":20},"2027-12-31",{"name":206,"class":207},"National Cancer Institute (NCI)","NIH",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":235},"100582092","phase-1-a-study-to-assess-adverse-events-and-change-in-disease-activity-of-intravenously-iv-infused-abbv-324-in-adult-participants-with-hepatocellular-cancer-hcc-or-squamous-cell-non-small-cell-lung-cancer-lusc-100582092","NCT06858813","A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-324 in Adult Participants With Hepatocellular Cancer (HCC) or Squamous-Cell Non-Small Cell Lung Cancer (LUSC)","A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV 324 in Adults With Hepatocellular Cancer or Squamous Cell Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Hepatocellular cancer (HCC) only: Child-Pugh A classification within 7 days before Cycle 1, Day 1 dosing.\n* Laboratory values meeting the criteria outlined in the protocol.\n* QT interval corrected for heart rate (QTc) \\\u003C 470 msec (using Fridericia's correction), no Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.\n* Measurable disease per RECIST version 1.1.\n* Part 1 and Part 2 - participants with HCC meeting the following disease activity criteria:\n\n  * Locally advanced or metastatic and\u002For unresectable HCC with diagnosis confirmed by histology or cytology. Participants with fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma\u002FHCC are not eligible to enroll.\n  * Disease that is not amenable to surgical and\u002For locoregional therapies, or progressive disease after surgical and\u002For locoregional therapies. For participants who progressed after locoregional therapy for HCC, locoregional therapy must have been completed \\>= 28 days prior to baseline scan for the current study.\n  * Part 1: Failure of at least 1 prior systemic treatment for HCC.\n  * Part 2: Failure of at least 1 prior systemic treatment consisting of an immune checkpoint inhibitor (CPI) containing regimen for HCC, including but not limited to, atezolizumab in combination with bevacizumab or tremelimumab in combination with durvalumab. Note: Participants who have received prior lenvatinib will not be eligible for Part 2.\n* Part 1 only - participants with squamous-cell non-small cell lung cancer (LUSC) meeting the following disease activity criteria:\n\n  * Advanced or metastatic LUSC that is not amenable to surgical resection.\n  * Must have failed at least 1 prior line of therapy that included at least platinum-based chemotherapy and an immune CPI, and\u002For an appropriate targeted therapy (if applicable), or is not suitable for other approved therapeutic options that have demonstrated clinical benefit at the judgment of the investigator. Participants should have no more than 2 lines of prior cytotoxic chemotherapy excluding neoadjuvant and\u002For adjuvant. Participants who are intolerant of standard therapy are eligible.\n\nExclusion Criteria:\n\n* Unresolved clinically significant adverse events (AEs) \\> Grade 1 from prior anticancer therapy except for alopecia.\n* Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue with antiepileptic therapy if required.\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* History of clinically significant, intercurrent lung-specific illnesses including, but not limited to:\n\n  * Underlying pulmonary disorder (i.e., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, dependence on supplemental oxygen, etc.).\n  * Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at Screening.\n* Must have discontinued anticancer therapy with antineoplastic intent including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 14 days or 5 half lives of the drug (whichever is shorter) prior to the first dose of ABBV-324. Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is permitted and not participant to a washout period.",{"count":216,"type":20},232,[54],"HCC is a common cancer worldwide and a leading cause of cancer-related death. Lung cancer is the most frequently diagnosed cancer in the world, and the leading cause of cancer deaths. The purpose of this study is to assess adverse events and change in disease activity when ABBV-324 is given to adult participants to treat hepatocellular cancer (HCC) or squamous-cell non-small cell lung cancer (LUSC).\n\nABBV-324 is an investigational drug being developed for the treatment of HCC and LUSC. Study doctors put the participants in groups called arms. Each arm receives ABBV-324 alone (monotherapy) or a comparator drug, lenvatinib followed by a safety follow-up period. Approximately 232 HCC or LUSC will be enrolled in the study in approximately 45 sites worldwide.\n\nIn the dose escalation stage participants will be treated with increasing intravenous (IV) doses of ABBV-324 until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will receive ABBV-324, or a comparator of oral lenvatinib. The study will run for a duration of approximately 6.5 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[28,220],"Squamous-Cell Non-Small Cell Lung Cancer",[28,220,222,223,224,225],"LUSC","HCC","ABBV-324","Lenvatinib","2026-03-23",{"date":228,"type":34},"2026-03-25",{"date":230,"type":34},"2025-04-14",{"date":232,"type":20},"2030-09",{"name":234,"class":74},"AbbVie",22,{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":119,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":251,"leadSponsor":253,"locationsCount":42},"100328115","tumor-cell-and-dna-detection-in-the-blood-urine-and-bone-marrow-100328115","NCT03551951","Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow","Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers and Subjects Undergoing Lung Cancer Screening","Inclusion Criteria:\n\n* Subjects older than 18 years.\n* Subjects of all genders and ethnicities.\n* Subjects with the diagnosis of a solid cancer (n=100) of all stages will be included (lung, esophageal, stomach, bile duct\u002Fpancreas, colorectal, melanoma, sarcoma).\n* Ten patients with no present suspicion and no previous history of any cancer (except basal cell cancer of the skin) that undergo surgeries for other benign indications will serve as controls (n=10).\n* In patients undergoing surgery for cancer the histopathology should preferably be pathologically proven by a previous or novel biopsy. Yet, patients with a high cancer suspicion by radiology and clinical picture that undergo cancer surgery will not be excluded. No additional biopsies, testing or interventions will be performed for the purpose of this study if the medical treatment will not require it.\n* Subjects must be capable of giving informed consent.\n* Lung cancer screening eligibility criteria (n=100): 55-80 years old, \\>30 pack years smoking history, and current smoker or have quit within the last 15 years)\n\nExclusion Criteria:\n\n* Pregnant women.\n* Subjects with the concurrent diagnosis of an active secondary (synchronous) malignancy besides basal cell carcinoma of the skin will be excluded, if there is evidence of disease burden or if the patient is currently being treated with chemotherapy.\n* Subjects with a hemoglobin of \\\u003C8g\u002Fdl in the morning of the procedure will be excluded.\n* In subjects who require intraoperative transfusions of \\>4 units of red packed blood cells (RPBCs), no further blood will be drawn for CTC\u002FDTC\u002FcfDNA analysis during surgery or on postoperative day 1.\n* In patients with coagulation disorders that could lead to significant bleeding (such as hemophilia, significant thrombocytopenia) requiring prophylactic administration of coagulative products, no bone marrow aspiration will be performed.",{"count":244,"type":20},320,"Patients with resectable solid primary cancers and even limited number of metastases are potentially curable. However, most patients develop recurrences despite surgery. Also, early detection of lung cancer with low dose CT screening may cure patients at an early stage. Circulating and disseminated tumor cell (CTC\u002FDTC) and circulating cell-free (cf) DNA isolation from the blood, urine and bone marrow will increase understanding of cancer spread and advance knowledge to develop individualized therapies and improve screening.",[163,93,94,98,28,125],"2025-10-03",{"date":249,"type":34},"2025-10-08",{"date":135,"type":34},{"date":252,"type":20},"2027-12-30",{"name":139,"class":41},{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":261,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":269,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":42},"100432565","phase-2-neoantigen-dendritic-cell-vaccine-and-nivolumab-in-hcc-and-liver-metastases-from-crc-100432565","NCT04912765","Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC","An Open Label, Single-arm, Phase II Neoantigen (NA) Dendritic Cell (DC) Vaccine and Anti-PD1 (Nivolumab) as Adjuvant Treatment in Resected Hepatocellular Carcinoma (HCC) (Group A) and Liver Metastases From Colorectal Cancer (CRLM) (Group B)","Inclusion Criteria:\n\nHCC specific criteria (Group A):\n\n* Participants must have either newly diagnosed or recurrent HCC, confirmed by histology\u002Fcytology or clinically by AASLD criteria in cirrhotic subjects amenable for management with curative intent by resection (with or without the addition of local ablation), if they fulfil the following radiological criteria.\n\n  1. Up to three tumours, at least one with a diameter \\> 3cm\n  2. More than three tumours, none with a diameter \\> 5 cm\n  3. Recurrent HCCs are permitted if they were previously treated with curative intent (e.g. by surgery or ablative methods) and with liver-limited recurrence fulfilling criteria (a) and (b)\n* Child-Pugh Score 5 or 6\n* All participants are required to have imaging studies (CT chest, tri-phasic CT\u002FMRI of the liver, contrast-enhanced CT\u002FMRI of abdomen and pelvis and other suspected\u002Fknown sites of disease, and bone scans if indicated) confirming no-extra-hepatic metastatic disease within 12 weeks prior to study enrolment.\n\nCRLM specific criteria (Group B):\n\n* Patients with histologically- or cytologically-diagnosed colorectal cancer with liver-limited metastases are eligible to enrol if:\n\n  1. There are no other sites of metastases aside from the liver confirmed by imaging studies (contrast-enhanced CT chest, abdomen and pelvis or contrast-enhanced CT chest and MRI abdomen and pelvis and other suspected sites of disease, and bone scans if indicated) at least 12 weeks prior to study enrolment AND\n  2. The liver metastases are amenable and planned for curative surgical resection with or without the addition of local ablation AND\n  3. The primary colorectal tumour had previously been resected or is amendable and planned for surgical resection.\n* Participants must have received peri-operative chemotherapy or are being planned for adjuvant chemotherapy after curative surgical resection\n* Participants with rectal cancer who received neoadjuvant radiation or are planned for adjuvant radiation are allowed into the study.\n\nGeneral Inclusion Criteria:\n\n* Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC defined as follows:\n\n  1. Non-HBV non-HCV related HCC\n  2. HBV-HCC:\n\n     1. Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen), OR\n     2. Chronic HBV infection as evidenced by detectable HBV surface antigen or HBV DNA. Participants with chronic HBV infection must be on antiviral therapy\n  3. HCV-HCC:\n\n     1. Resolved HCV infection as evidenced by detectable antibody, OR\n     2. Chronic HCV infection as evidenced by detectable HCV RNA.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Screening laboratory values must meet the following criteria, and should be obtained within 28 days prior to study enrolment:\n\n  1. Adequate hematologic function:\n\n     1. WBC ≥ 2,000\u002FμL (stable, off any growth factor within 4 weeks of study treatment administration);\n     2. Neutrophils Absolute ≥ 1,500\u002FμL (stable, off any growth factor within 4 weeks of study treatment administration);\n     3. Hemoglobin ≥ 8.5 g\u002FdL (may be transfused to meet this requirement);\n     4. Platelet count ≥ 60 × 103\u002FμL (transfusion to achieve this level is not permitted);\n  2. Adequate hepatic function:\n\n     1. Serum albumin \\> 2.8 g\u002FL (transfusion to meet this level is not permitted); and\n     2. Serum total bilirubin \\\u003C 3 mg\u002FdL, and\n     3. Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 5 × ULN;\n  3. Prothrombin time (PT)-international normalized ratio (INR) \\\u003C 2.3 or Prothrombin time (PT) \\\u003C 6 seconds (transfusion to achieve this level is not permitted)\n  4. Adequate renal function with a serum creatinine of \\\u003C 1.5 × ULN or a creatinine clearance \\> 40 mL\u002Fmin (Cockcroft-Gault formula)\n* Age and Reproductive Status:\n\n  1. Males and females, ages 21 or older.\n  2. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.\n  3. Women must not be breastfeeding.\n  4. WOCBP must agree to follow instructions for method(s) of contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of study treatment with nivolumab and 7 months after the last dose of study treatment.\n  5. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of study treatment with nivolumab and 7 months after the last dose of study treatment. In addition, male participants must be willing to refrain from sperm donation during this time.\n  6. Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, and still must undergo pregnancy testing as described in this section.\n\nExclusion Criteria:\n\nHCC specific criteria (Group A):\n\n* Target Disease Exceptions\n\n  1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n  2. Any evidence of tumour metastasis or co-existing malignant disease.\n  3. Participants showing evidence of macrovascular invasion on imaging tests.\n  4. Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation.\n  5. Participants previously receiving any prior systemic therapy, trans-arterial embolization or chemoembolisation (TAE\u002FTACE), selective internal radiation therapy (SIRT) and stereotactic radiation therapy (SBRT) for HCC.\n\n     CRLM specific criteria (Group B)\n* Target Disease Exceptions a) Patients with extra-hepatic colorectal metastases.\n\nGeneral Inclusion Criteria:\n\n* Medical Conditions\n\n  1. Active co-infection with:\n\n     1. Both hepatitis B and C as evidenced by detectable HBV surface antigen (HBs Ag) or HBV DNA and HCV RNA, OR\n     2. Hepatitis D infection in participants with hepatitis B\n  2. Known positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n  3. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results.\n  4. Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n  5. Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n  6. Prior malignancy active within the previous 3 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 prostate, cervix, or breast.\n* Prior\u002FConcomitant Therapy\n\n  1. Participants receiving or expected to receive IFN-based therapies during the study period.\n  2. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n  3. Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to start of therapy.\n* Physical and Laboratory Test Findings\n\n  a. Positive pregnancy test\n* Allergies and Adverse Drug Reaction\n\n  1. History of severe hypersensitivity to a monoclonal antibody.\n  2. History of allergy or hypersensitivity to study drug components\n* Other Exclusion Criteria\n\n  1. Prisoners or participants who are involuntarily incarcerated.\n  2. Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.","21 Years",{"count":263,"type":20},60,[55],"This is a single arm phase II study of adjuvant intra-dermal NA DC vaccine combined with intravenous nivolumab in patients with resectable HCC (group A) or CRLM (group B) planned for curative surgery (with\u002Fwithout local ablation).",[26,28,125,267,268],"Colorectal Carcinoma","Liver Metastases",[270,271,272,125,28,273,274],"Tumour neoantigens","Tumor neoantigens","Cancer vaccine","Immunotherapy","anti-PD1","2025-09-22",{"date":277,"type":34},"2025-09-23",{"date":279,"type":34},"2021-04-15",{"date":281,"type":20},"2027-06",{"name":283,"class":41},"National Cancer Centre, Singapore",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":21,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":305,"locationsCount":307},"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":292,"type":20},20,[54],"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)",[296,26,28],"Resectable Hepatocellular Carcinoma",[296,26,28,298],"Liver Cancer","2025-08-26",{"date":301,"type":34},"2025-09-02",{"date":303,"type":34},"2023-04-21",{"date":36,"type":20},{"name":306,"class":41},"Jiping Wang, MD, PhD",3,{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":42},"100585191","hepquant-study-to-assess-the-role-of-blood-based-biomarkers-and-quantitative-mr-imaging-for-patients-receiving-radiation-therapy-for-liver-cancer-100585191","NCT06899152","HepQuant: Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer","HepQuant: Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer","HepQuant","The following criteria must be met for subjects to be considered for the trial. Additional exclusion criteria must be met for subjects interested in the HepQuant subset of the trial. The first 20 qualifying subjects will be enrolled for the additional HepQuant test.\n\nInclusion Criteria:\n\n* Age \\> 18\n* Patient has the psychological ability and general health needed to provide informed consent, completion of study requirements, and required follow-up\n* Patient provides study-specific informed consent prior to study entry\n* All primary histologies (Hepatocellular carcinoma or Cholangiocarcinoma) as well as hepatic metastases are eligible\n* Prior history of radiation therapy (external beam or radioembolization) is allowed, with no limit to the number of prior courses of radiation therapy\n* Any number of lesions (with no size limit) of pathologically documented (histologically or cytologically) or radiographically proven tumor\u002Fmetastasis that are being targeted\n* Prior history of liver resection, transarterial chemoembolization (TACE), or ablation are allowed with no restriction on number of prior therapies, or time from current study registration\n* Prior history of chemotherapy, immunotherapy, or targeted biological therapy is allowed\n* Concurrent enrollment on other prospective registry or treatment intention trials is allowed\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding females\n* Subjects with history of claustrophobia impacting ability to perform MRI during the study\n* Subjects who fulfill any of the contraindications for MRI; examples include any ferromagnetic material, any metallic shrapnel or fragments or implanted electronic devices contained within the body or metal-containing tattoos\n* Unable to participate in MR assessments due to physical limitations of equipment tolerances (MRI bore size and\u002For weight limit)\n* Any person unable to lie still within the environment of the MRI scanner or maintain a breath hold for the required period to acquire images\n\nExclusion criteria for HepQuant SHUNT DuO testing ONLY:\n\n* Known history or suspected hypersensitivity to human serum albumin, or its preparations\n* Subjects with extensive resection of large segments of small intestine (short gut) or severe gastroparesis (e.g., diabetic or medication-induced gastroparesis)\n* Subjects on either a non-selective beta blocker (propranolol, nadolol), or an angiotensin converting enzyme (ACE) inhibitor, or angiotensin receptor blocker (ARB) who are unwilling or unable to delay taking their normal dose the morning of their testing\n* Subjects who are allergic to any ingredient in the formulations or components in the HepQuant SHUNT DuO kit including the human serum albumin (HSA) or cholate compounds (theoretical - none yet reported)\n* Subjects unwilling or unable to fast for at least 5 hours. Fasting means no intake of food or food supplements, including fiber preparations or biosimilars; or any preparations or resins (cholestyramine, colestipol, colesevelam) that might act within the gut lumen to bind the orally administered d4-cholate in the HepQuant test.",{"count":317,"type":20},40,[23],"This is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases regardless of primary histology, that are undergoing photon radiation either in the de-novo or re-irradiation setting. The goal of this study is to prospectively evaluate the feasibility of using quantitative multiparametric MRI to monitor liver function at baseline and following liver radiation therapy.",[298,26,28,321,268],"Cholangiocarcinoma",[323,324,325],"Blood-based biomarkers","Quantitative MR imaging","Radiotherapy","2025-07-22",{"date":328,"type":34},"2025-07-23",{"date":330,"type":34},"2025-07-16",{"date":332,"type":20},"2031-07",{"name":334,"class":41},"Montefiore Medical Center",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":21,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":42},"100473911","phase-2-durvalumab-and-tremelimumab-in-combination-with-propranolol-and-chemotherapy-for-treatment-of-advanced-hepatopancreabiliary-tumors-blocked-100473911","NCT05451043","Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)","A Study to Evaluate the Efficacy of Propranolol in Boosting Immunotherapy in Hepatocellular Carcinoma, Cholangiocarcinoma and Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n1. Patients must be 18 years of age or older.\n2. Body Weight \\>30kg\n3. Life expectancy of at least 12 weeks\n4. Patients must have a diagnosis of histologically documented advanced pancreatic adenocarcinoma, hepatocellular carcinoma, or BTC not amenable to curative intent local therapy or surgery. For the histologies there must only one histology type present ie not mixed cholangiocarcinoma\u002FHCC. For the HCC cohort if tissue biopsy if histological diagnosis is not possible, diagnosis can be made clinically by American Association for the study of liver diseases (AASLD) criteria in cirrhotic patients.\n5. Radiation therapy (palliative or curative) must have been completed at least 4 weeks prior to first study treatment and patients must have toxicities recovered to grade 1 or less.\n6. Patients must be capable of providing consent to enrolment and treatment.\n7. Patients with a performance status of ECOG 0-2(15) will be eligible for enrolment (see Appendix 1).\n8. Measurable disease must be present according to RECIST criteria V1.1(16) (see Appendix 3).\n9. Women of child-bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 50 years in the absence of other biological or physiological causes.\n10. Patients (men and women) of childbearing \u002F reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n11. Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 90 days after the last dose of durvalumab monotherapy or 180 days after the last does of durvalumab + tremelimumab combination therapy.\n12. Male patients should agree to not donate sperm during the study and for a period of at least 6 months after last dose of study drug.\n13. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.\n14. The following adequate organ function laboratory values must be met:\n\nHematological:\n\n• Absolute neutrophil count (ANC) \\>1.5 x109\u002FL\n\n* For the Hepatocellular cohort Platelet count \\>\u002F 1.0 x109\u002FL is adequate • Platelet count \\>100 x109\u002FL\n* For the Hepatocellular cohort Platelet count \\>\u002F 65 x109\u002FL is adequate • Hemoglobin \\>9 g\u002FdL (may have been transfused)\n\nRenal:\n\n• Estimated creatinine clearance ≥ 45 mL\u002Fmin according to the Cockcroft-Gault formula (or local institutional standard method)\n\nHepatic:\n\n* Total serum bilirubin \\\u003C1.5x ULN\n\n  o For the HCC cohort bilirubin ≤ 2 x ULN\n* AST and ALT \\\u003C2.5x ULN (or ≤ 5 x ULN for patients with documented metastatic disease to the liver)\n\nExclusion Criteria:\n\n1. Patients who have received prior palliative systemic treatment for their advanced cancer.\n2. History of pneumonitis requiring treatment with steroids.\n3. History of active interstitial lung disease.\n4. For HCC patients they must have a Child Pugh status of A.\n5. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n6. 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\n7. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) \\\u003C\\\u003Cfor durvalumab monotherapy and durvalumab + tremelimumab combination studies this criterion can be removed. For durvalumab ±tremelimumab in combination with an agent with pro-arrhythmic potential or where effect of the combination on QT is not known if this criterion should be retained.\n8. History of another malignancy or a concurrent malignancy;\n\n   • Exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ. As well patients with a resected malignancy that did not require systemic therapy post-surgery are allowed.\n9. Active brain metastases or leptomeningeal disease.\n\n   • Patients with treated brain metastases that have been treated, are off steroids and anticonvulsants and have imaging documenting stability of brain metastases for 6 weeks post treatment will be eligible for enrolment.\n10. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n11. Prior organ transplantation including allogeneic stem-cell transplantation.\n12. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.\n13. Active infection requiring systemic therapy or Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, 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. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients known positive for HIV.\n14. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE v5.0 Grade ≥ 3).\n15. Other severe acute or chronic medical conditions including inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n16. Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 grade \\> 1); however, alopecia, sensory neuropathy ≤ grade 2, or other toxicities ≤ grade 2 not constituting a safety risk based on investigator's judgment are acceptable.\n17. Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.\n18. 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 to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy.\n19. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n20. 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.\n21. Prior randomisation or treatment in a previous durvalumab and\u002For tremelimumab clinical study regardless of treatment arm assignment.\n22. Asthma requiring corticosteroid inhalers and having been admitted within the last year for an asthma exacerbation",{"count":343,"type":20},62,[55],"A single-arm, interventional study combining Immunotherapy and propranolol with\u002Fwithout chemotherapy and propranolol\n\n1. Pancreatic Cancer Durvalumab will be administered once every 4 weeks, in combination with gemcitabine + nab-paclitaxel (day 1\u002F8\u002F15) and continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients.\n2. HCC Durvalumab will be administered once every 4 weeks in combination with continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients.\n3. Biliary Tract Cancer (BTC, Cholangiocarcinoma of the gallbladder or bile ducts) Durvalumab will be administered once every 3 weeks, in combination with cisplatin + gemcitabine (day 1\u002F8) and continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients.",[98,28,88,321],"2025-06-24",{"date":349,"type":34},"2025-06-26",{"date":351,"type":34},"2023-07-05",{"date":353,"type":20},"2029-10-01",{"name":355,"class":41},"AHS Cancer Control Alberta",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":21,"phases":366,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":42},"100587960","phase-2-a-study-of-shr-1826-monotherapy-or-in-combination-with-immunotherapy-in-the-treatment-of-advanced-hepatocellular-cancer-100587960","NCT06935175","A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in the Treatment of Advanced Hepatocellular Cancer","A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in Patients With Advanced Hepatocellular Cancer","Inclusion Criteria:\n\n1.18-75 years old, male or female.\n\n2.Hepatocellular carcinoma diagnosed histologically or cytologically, and not suitable for radical surgery;\n\n3.Failure of at least one line of standard treatment (progression or intolerance);\n\n4.According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one measurable lesion diagnosed by imaging (a lesion that has received local treatment needs to show clear progression to be considered a measurable lesion);\n\n5.Expected survival time ≥ 12 weeks;\n\n6.Normal function of major organs;\n\n7.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up.\n\nExclusion Criteria:\n\n1. Known or suspected to have a severe allergic history to the drugs related to this study (including drugs of the same type);\n2. Evidence of liver decompensation: including but not limited to symptomatic ascites, esophageal-gastric variceal bleeding, hepatic encephalopathy, hepatorenaHave central nervous system metastasis;l syndrome, sepsis, etc.;\n3. Have central nervous system metastasis;\n4. Have a history of organ transplantation or are preparing for organ transplantation (including but not limited to liver transplantation);\n5. Have a history of abdominal wall fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before the start of treatment in the study;\n6. Other situations in which the investigator deems that the subject should not be included.","75 Years",{"count":365,"type":20},53,[55],"The study was designed to evaluate the efficacy and safety of SHR-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients.",[28],[370],"hepatocellular cancer","2025-04-17",{"date":373,"type":34},"2025-04-20",{"date":375,"type":20},"2025-05-01",{"date":377,"type":20},"2028-05-31",{"name":379,"class":41},"Shanghai Zhongshan Hospital",{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":16,"minAge":388,"maxAge":389,"enrollmentInfo":390,"targetDuration":4,"studyType":21,"phases":391,"briefSummary":392,"conditions":393,"keywords":395,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":42},"100515493","phase-2-atezolizumab-plus-bevacizumab-alone-or-combined-with-external-beam-radiotherapy-for-hcc-with-macrovascular-invasion-100515493","NCT05992220","Atezolizumab Plus Bevacizumab Alone or Combined with External Beam Radiotherapy for HCC with Macrovascular Invasion","A Randomized, Multicenter, Open-Label, Phase II Trial of Atezolizumab Plus Bevacizumab Alone or Combined with External Beam RadioTherapy for HepatoCellular Carcinoma with Macrovascular Invasion (ALERT-HCC)","ALERT-HCC","Inclusion Criteria:\n\n* Older than 19 years of age, lower than 80 years of age\n* Child-Pugh class A hepatic function\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n* Patients with HCC \\[diagnosed according to AASLD guidelines\\] invading the intrahepatic vascular system\n* No prior systemic therapy for HCC\n* At least one measurable HCC lesion with ≥ 1cm diameter\n* Adequate hematologic and organ function\n\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Absolute neutrophil count ≥ 1,000 \u002Fmm3\n  * Platelet ≥ 50,000\u002F mm3 without transfusion\n* Total bilirubin ≤ 2.5 mg\u002FdL\n\nExclusion Criteria:\n\n* Treatment history of prior systemic treatment of HCC\n* Liver transplant recipients\n* Patients with peptic ulcer, untreated or incompletely treated varices with bleeding or high-risk for bleeding\n* Any serious illness (e.g., active infection or inflammatory condition) or uncontrolled severe medical comorbidity\n* A history of treated malignancy (other than HCC) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years\n* Abdominal\u002Fpelvic radiotherapy within 28 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment","20 Years","79 Years",{"count":52,"type":20},[55],"The recent global IMbrave150 study evaluated the combination of atezolizumab and bevacizumab versus sorafenib in 501 patients with advanced or metastatic Hepatocellular Carcinoma (HCC). The median overall survival (OS) was notably better in the atezolizumab\u002Fbevacizumab group. However, for HCC patients with intrahepatic macrovascular invasion (MVI), the prognosis remains poor, indicating a significant unmet need in this group.\n\nExternal Beam Radiotherapy (EBRT) has shown promising results in treating HCC with MVI, especially when used in combination with trans-arterial chemoembolization (TACE). It has been reported that radiotherapy may make tumor cells more susceptible to immune-mediated therapy, potentially enhancing the effects of atezolizumab and bevacizumab.\n\nThus, this study aims to investigate the efficacy and safety of atezolizumab\u002Fbevacizumab alone versus atezolizumab\u002Fbevacizumab in combination with EBRT in HCC patients with macrovascular invasion.",[26,28,29,394,298],"Hepatocellular Carcinoma Stage IV",[396],"HCC; vascular invasion; portal vein tumor thrombosis; BCLC stage C","2025-02-19",{"date":399,"type":34},"2025-02-21",{"date":401,"type":34},"2022-10-22",{"date":403,"type":20},"2026-03",{"name":405,"class":41},"Asan Medical Center",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":21,"phases":415,"briefSummary":417,"conditions":418,"keywords":419,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":42},"100453512","phase-4-atezolizumab-and-bevacizumab-pre-liver-transplantation-for-patients-with-hepatocellular-carcinoma-beyond-milan-criteria-100453512","NCT05185505","Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria","Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria: A Feasibility Study","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years old at the time of signing Informed Consent Form\n2. Measurable or evaluable disease per RECIST v1.1 or mRECIST of unresectable HCC outside of Milan criteria\n3. Histologically proven HCC, without extrahepatic disease. Patients who consent to a fresh tissue biopsy, and under the discretion of the Investigators, will provide a baseline biopsy sample for diagnosis and correlative studies. Archival tumor tissue may be used to confirm HCC in patients who do not consent to a fresh tissue biopsy.\n4. Prior remote LRT is allowed if new lesions or local disease recurrence are present\n5. Must be eligible for liver transplantation, defined in Section 10.4\n6. Eligible and suited to receive TACE procedure(s)\n7. Child-Pugh score ≤A6\n8. Eastern Cooperative Oncology Group (ECOG) score 0-1\n9. Life expectancy of ≥ 6 months\n10. Adequate hematological and end-organ function, defined by the following laboratory test results obtained within 14 days prior to study initiation:\n\n    1. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL\n    2. Lymphocyte count ≥ 0.5 x 10\\^9\u002FL (500\u002FuL)\n    3. Platelet count \\> 75 x 109\u002FL\n    4. Hemoglobin \\> 9 g\u002FdL\n    5. Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN)\n    6. Aspartate transaminase (AST),alanine aminotransferase (ALT), and alkaline phosphatase (ALP) \\\u003C 2.5 x ULN\n    7. Serum albumin \\> 2.7 g\u002FdL\n    8. Serum creatinine \\\u003C 1.5x ULN or calculated creatinine clearance \\\u003C 50 ml\u002Fmin\n    9. Urine dipstick for proteinuria ≥ 2+ unless a 24-hour urine protein \\\u003C 1 g of protein is demonstrated\n    10. International normalized ratio (INR) ≤ 1.5 or partial thromboplastin time (PTT) ≤ 1.5 x ULN for patients not receiving anti-coagulation. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or PTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least two weeks prior to the first study treatment.\n11. No evidence of a Grade 2 or higher esophageal and\u002For gastric varices. Patients must have an esophagogastroduodenoscopy (EGD) within 6 months prior to initiating the study treatment. See Section 8.7.1.2.\n12. No history of hemoptysis (≥ 1\u002F2 teaspoon of bright red blood per episode) within 1 month of study enrollment\n13. Negative HIV test at screening or transplant workup\n14. Negative hepatitis B surface antigen (HBsAg) test at screening or transplant workup\n15. Negative total hepatitis B core antibody (HBcAb) test at screening or transplant workup, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening or transplant workup. The HBV DNA test will be performed only for patients who have a negative HBsAg test and a positive total HBcAb test.\n16. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, as defined below:\n\n    1. Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C1% per year during the treatment period and for 6 months after the final dose of atezolizumab\u002Fbevacizumab Females who receive a LT are required to maintain abstinence or contraception until the End of Study.\n    2. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n    3. Examples of contraceptive methods with a failure rate of \\\u003C1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n    4. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n17. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:\n\n    1. With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of atezolizumab\u002Fbevacizumab to avoid exposing the embryo. Men must refrain from donating sperm during this same period. Males who receive a LT are required to maintain these criteria until the End of Study.\n    2. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of preventing drug exposure.\n18. Stated willingness to comply with all study procedures and availability for the duration of the study\n19. Women of childbearing potential must have a negative serum or urine pregnancy test result within 14 days prior to initiation of study treatment.\n\nExclusion Criteria:\n\n1. Known fibrolamellar HCC, sacromatoid HCC, or mixed cholangiocarcinoma and HCC\n2. Previous systemic therapy for HCC prior to study enrollment\n3. Planned or prior multi-organ transplant or prior solid organ or allogeneic stem cell transplantation\n4. History of Grade ≥4 venous thromboembolism\n5. History or evidence upon physical or neurological examination of central nervous system (eg seizures) unrelated to cancer unless adequately treated with standard medical therapy. Anticonvulsants (stable dose) are allowed.\n6. Moderate or severe ascites\n7. History of hepatic encephalopathy\n8. Inadequately controlled hypertension (defined as systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg)\n9. History of hypertensive crisis or hypertensive encephalopathy\n10. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to drug administration\n11. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n12. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)\n13. Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to initiation of study treatment, or anticipation of need for major surgical procedure during the Treatment Phase of the study\n\n    • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device within 7 days prior to initiation of study treatment. Placement of a vascular access device should be at least 2 days prior to initiation of study treatment.\n14. History of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, grade 2 or higher untreated esophageal or gastric varices or active GI bleeding within 6 months prior to treatment\n15. Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or high risk for bleeding. Patients 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. Patients who have undergone an EGD within 6 months prior to initiating the study treatment do not need to repeat the procedure.\n16. Serious, non-healing wound, active ulcer, or untreated bone fracture\n17. Other malignancy within 5 years prior to randomization, except for localized cancer in situ, such as basal or squamous cell skin cancer\n18. Current or recent (\\\u003C10 days prior to initiation of study treatment) use of aspirin (\\>325 mg\u002Fday), or clopidogrel (\\>75 mg\u002Fday). Note: The use of full-dose oral or parenteral anticoagulants for therapeutic purpose is permitted as long as the INR and\u002For a PTT is within therapeutic limits (according to institution standards) within 14 days prior to initiation of study treatment and the patient has been on a stable dose of anticoagulants for ≥2 weeks prior to initiation of study treatment. Prophylactic use of anticoagulants is allowed. However, the use of direct oral anticoagulant therapies such as dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) is not recommended due to bleeding risk.\n19. Pregnancy (positive pregnancy test) or lactation, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study drugs\n\n    o Women of childbearing potential must have a negative serum or urine pregnancy test result within 28 days prior to initiation of study treatment.\n20. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n\n    • Patients with indwelling catheters (e.g., PleurX®) are allowed\n21. Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n22. 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, Wegener granulomatosis, 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 eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (eg, patients with psoriatic arthritis are excluded) are eligible for the study provided all 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\n23. History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n24. Active tuberculosis\n25. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n26. Treatment with a live, attenuated vaccine (e.g., FluMist®) within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n27. Current treatment with anti-viral therapy for HBV\n28. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n29. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n30. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the Treatment Phase, with the following exceptions:\n\n    * Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.\n    * Patients who received mineralocorticoids (eg, fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n31. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n32. Known allergy or hypersensitivity to any component of the Atezlizumab and Bevacizumab formulation, such as a known hypersensitivity to Chinese hamster ovary cell products\n33. Inability to comply with study and\u002For follow-up procedures\n34. Active infection requiring IV antibiotics within 2 weeks prior to initiation.\n\n    * Note: Placement of a vascular access device should be at least 2 days prior to initiation of study treatment.\n    * Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n35. Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n36. History of leptomeningeal disease\n37. Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure\n38. History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to active peptic ulcer disease, diverticulitits, or colitis.\n39. Chronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID). Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed\n40. Uncontrolled tumor-related pain\n\n    * Patients requiring pain medication must be on a stable regimen at study entry.\n    * Symptomatic lesions (eg, bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.",{"count":414,"type":20},24,[416],"PHASE4","Patients with hepatocellular carcinoma (HCC) beyond Milan Criteria (MC) who are transplant-eligible will be treated with 6 months of neoadjuvant\u002Fdownstaging atezolizumab plus bevacizumab while receiving standard of care transarterial chemoembolization (TACE). We hypothesize that atezolizumab and bevacizumab can appropriately bridge patients with HCC beyond MC to transplantation and not increase the risk of 1-year post-transplant rejection.",[26,28],[420,421,422,59,423],"Bevacizumab","atezolizumab","Neoadjuvant Therapy","Liver Transplantation","2023-01-31",{"date":426,"type":34},"2023-02-01",{"date":428,"type":34},"2023-01-30",{"date":430,"type":20},"2027-10-31",{"name":432,"class":41},"The Methodist Hospital Research Institute",{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":21,"phases":442,"briefSummary":443,"conditions":444,"keywords":450,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":5},"100346156","predictive-value-of-progastrin-titer-at-diagnosis-and-of-progastrin-kinetics-during-treatment-in-cancer-patients-100346156","NCT03787056","Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients","ONCOPRO","* Histologically and\u002For cytologically documented (documentation obtained before or after diagnostic surgical procedure when clinical suspicion is strong), cancers for the following cohorts:\n\n  o Breast carcinomas\n\n  o Gastric carcinomas\n\n  o Renal carcinomas\n\n  o Prostate carcinomas\n\n  o Lung carcinomas: NSCLC and SCLC\n\n  o Hepatocellular carcinomas\n\n  o Colorectal carcinomas\n  * Head and neck carcinomas\n  * Thyroid cancer\n  * Pancreatic carcinomas\n  * Ovarian adenocarcinomas\n  * Glioblastoma\n  * Endometrial adenocarcinomas\n  * Bladder carcinoma\n  * Superficial Oesophago-gastric carcinomas\n  * Diffuse Large B-cell Lymphomas\n* Patient older than 18 years.\n* Patients who gave its written informed consent to participate to the study\n* Patients affiliated to a social insurance regime\n\nSpecific inclusion criteria for curative treatment strategy cancer patients:\n\n* Indication of a treatment strategy with curative intent (surgery; radiotherapy; chemotherapy; hormonotherapy; targeted agents…)\n* Patient naïve of anticancer treatments for the considered cancer\n* A prior anti-cancer treatment is allowed if this treatment was performed with curative intent, and if it did not include systemic chemotherapy, and if a complete remission ≥ 6 months was observed in between the end of treatment and relapse. Previous local treatments for superficial lesions are allowed without any time restriction (for example among others, intravesical treatment for superficial bladder cancer lesions).\n\nSpecific inclusion criteria for non-curative treatment strategy cancer patients:\n\n* Indication of a treatment strategy with no curative intent (radiotherapy; chemotherapy; hormonotherapy; immunotherapy; targeted agents, non-curative surgery, …)\n* Patient naïve of anticancer treatments in non-curative setting (except for metastatic hormone-sensitive prostate cancer, see specific inclusion criteria).\n\nThe following tumor type specific inclusion criteria must be met in addition to the inclusion criteria listed above:\n\nBreast carcinomas\n\n• All cohorts:\n\n* Invasive breast ductal carcinoma, or\n* Invasive breast lobular carcinoma\n\n  * Curative intent treatment patient cohort:\n* Planned to be treated with surgery, with\u002Fwithout neo-adjuvant and\u002For adjuvant chemotherapy and\u002For anti-hormone treatment\n\nGastric carcinomas\n\n* All cohorts:\n\n  o Intestinal-type adenocarcinoma, or\n\n  o Diffuse cell type adenocarcinoma\n* Curative intent treatment patient cohort:\n\n  * Planned to be treated with surgery with\u002Fwithout neo-adjuvant treatment, with\u002Fwithout adjuvant treatment\n\nRenal carcinomas • All cohorts:\n\n* Any histology of renal cancer is accepted (non-clear cell renal cancer could be included)\n* A pathology proof of renal cell carcinoma is not necessarily provided if patients present typical radiologic characteristics of renal cancer on imaging\n\n  • Curative intent treatment patients cohort:\n* Planned to be treated with partial or total nephrectomy\n\nProstate carcinomas\n\n* Curative intent treatment patients cohort:\n\n  o Localized prostate cancer with high risk features : StageT2b , T2c or T3 and\u002For Gleason \\>= 4+3 and\u002For PSA \\>= 20 and\u002For N+\n\n  o Planned to be treated with radical prostatectomy or radiotherapy (potentially associated with androgen deprivation therapy). Brachytherapy and\u002For focused ultrasounds are not allowed.\n* Non-curative intent treatment patients cohort:\n\n  * Patients with metastatic castration resistant prostate cancer (mCRPC) defined by validated criteria of EAU, planned to be treated with doceteaxel or cabazitaxel or second generation hormone (i.e. abiraterone or enzalutamide). Patients have to be naïve of treatment for the castration resistant mCRPC. Patients that previously received docetaxel or a 1st or 2nd generation hormonotherapy for their hormone-sensitive prostate cancer in metastatic setting can be included.\n\nLung carcinomas treated by immunotherapy :\n\n• Non-curative intent patients cohort:\n\no NSCLC stage IV according to 8th TNM classification planned to be treated with immunotherapy, with\u002F without chemotherapy\n\nLung carcinomas excluding those treated with immunotherapy:\n\n* Curative intent treatment patients cohort:\n\n  o NSCLC histology only\n\n  o Stage I-II according to 8th TNM classification\n\n  o Stage IIIA-B according to 8th TNM classification\n\n  o Planned to be treated with radical treatment (surgery or radiotherapy with\u002Fwithout concurrent chemotherapy), potentially associated with neo-adjuvant or adjuvant treatment\n* Non-curative intent patients cohort:\n\n  * NSCLC or SCLC stage IV according to 8th TNM classification planned to be treated with a first line of chemotherapy, with\u002Fwithout associated treatments except immunotherapy (radiotherapy, targeted therapies…). Immunotherapy can be administrated for the subsequent lines of treatment.\n\nHepatocellular carcinomas A pathology proof of HCC is not necessarily provided if patients present typical radiologic characteristics of hepatocellular carcinoma on imaging\n\n* Absence or chronic hepatic encephalopathy, absence of refractory ascites\n\n  * Curative intent treatment patients cohort:\n* Indication of a treatment strategy with curative intent, except liver transplantation: surgical resection, monopolar radiofrequency ablation for HCC (1 to 3 nodules ≤3 cm) or multibipolar radiofrequency if nodule ≤4 cm).\n\n  • Non-curative intent patients cohort:\n* Indication of a treatment strategy with no curative intent: transarterial intra-hepatic chemoembolization, targeted therapies (tyrosine kinase inhibitors or monoclonal antibodies) or immune therapy.\n\nColorectal carcinomas\n\n• Curative intent treatment patients cohort:\n\no Lieberkühn adenocarcinoma associated with metastases planned to be treated with peri-operative chemotherapy +\u002F- targeted agent and interval surgery\n\nHead and neck carcinomas\n\n* All cohorts\n\n  o Head and neck squamous cell carcinoma from oral cavity, oropharynx, hypopharynx, larynx\n* Curative intent treatment patients cohort:\n\n  o Planned to be treated with a radical treatment (surgery and\u002For radiotherapy potentially associated with concurrent chemotherapy) with\u002Fwithout neo-adjuvant\u002Fadjuvant chemotherapy.\n* Non-curative intent treatment patients cohort:\n\n  o De novo metastatic or metastatic\u002Floco-regional relapse planned to be treated with chemotherapy and\u002For immunotherapy\n\nThyroid cancer • Curative intent patient cohort o Thyroid carcinoma differentiated, poorly differentiated, papillary, vesicular, Hurthle Cell o For which a iodine treatment is indicated (Iodine treatment will be discussed after surgery. In the case the histological result does not confirm a high risk thyroid cancer, patient will be withdrawn from the study. In the same way, if a iodine treatment is not recommended after surgery, patient will be withdrawn from the study. In both cases, patient will be replaced).\n\nPancreatic carcinomas\n\n• Curative intent patients cohort:\n\no Pancreas exocrine adenocarcinoma planned to be treated with initial surgery with\u002Fwithout neo-adjuvant chemotherapy and with\u002Fwithout adjuvant chemotherapy or radiotherapy\n\nOvarian adenocarcinomas • Non\u002Funcertain curative intent patients cohort:\n\no 1st platinum-sensitive relapse\n\n* High or low grade epithelial adenocarcinomas or carcinosarcoma\n* Planned to be treated with chemotherapy and\u002For PARP inhibitors based treatment, +\u002F- interval debulking surgery\n\nGlioblastoma • Curative intent patients cohort:\n\no Planned to be treated with surgical resection, followed by adjuvant temozolomide and radiotherapy\n\nEndometrial adenocarcinomas\n\n* Non-curative intent patients cohort:\n\n  o Type 1 (endometrioid or mucinous) or type 2 endometrial (serous, clear cell, undifferentiated carcinoma and carcinosarcoma) cancers\n\n  o Planned to be treated with non-curative systemic treatment for metastatic or advanced disease\n\nBladder carcinoma\n\n* Transitional cell carcinoma • Curative intent treatment patients:\n* Patients with localized muscle invasive bladder cancer (\\>=PT2)\n* Planned to be treated with neo-adjuvant cisplatin based chemotherapy, or immunotherapy or a combination of chemotherapy and immunotherapy\n\nSuperficial Oesophago-gastric cancer • Curative intent patients cohort:\n\no Superficial oesophago-gastric carcinomas (adenocarcinomas or epidermoid carcinomas) of Stage T1 planned to be treated by endoscopic surgery\n\nDiffuse Large B-Cell Lymphoma (DLBCL)\n\n• Curative intent patients cohort:\n\no Patients planned to be treated with R-CHOP (Rituximab-Cyclophosphamide, Hydroxyadriamycine, Oncovin, Prednisone)",{"count":441,"type":20},410,[23],"Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal.\n\nIn a healthy person, progastrin is not detectable in the peripheral blood. However, progastrin is abnormally released in the blood of patients with different cancers (colorectal, gastric, ovarian, breast, cervix uterus, melanoma…) The gene GAST coding for progastrin is a direct target gene of the WNT\u002Fß-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development.\n\nChronic activation of the WNT\u002Fß-catenin oncogenic pathway occurs in almost all human solid tumors and is a central mechanism in cancer biology that induces cellular proliferation, blocking of differentiation leading to primary tumor growth and metastasis formation.\n\nProgastrin measured in the peripheral blood of patients on treatments, could be a new powerful marker for diagnosis and prognosis at different stages.",[127,89,94,101,99,154,445,28,125,96,98,446,447,92,448,93,449],"Lung Cancer","Ovarian Cancer","Glioblastoma","Bladder Cancer","B-cell Lymphoma",[451,452,453],"dd","TUMOR MARKER","PROGASTRIN","2021-07-12",{"date":456,"type":34},"2021-07-16",{"date":458,"type":34},"2018-12-04",{"date":460,"type":20},"2028-01-04",{"name":462,"class":41},"Hospices Civils de Lyon",{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":472,"conditions":473,"keywords":477,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":42},"100305234","prospective-observational-trial-to-evaluate-quality-of-life-after-stereotactic-ablative-radiation-therapy-in-patients-with-hepatocellular-carcinoma-100305234","NCT03253536","Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma","LIVERCARE","Inclusion Criteria:\n\n* histologically or radiologically proven hepatocellular carcinoma\n* 1-3 lesions suitable for stereotactic radiation therapy\n* indication for SBRT according to multidisciplinary board evaluation\n* age \\>= 18 years\n* written informed consent for study participation\n* mental and verbal ability to complete standardized questionaires according to assessment by investigator (physician)\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* prior HCC specific systemic therapy\n* concurrent oncological systemic treatment\n* distant metastases\n* inadequate ability tobe compliant with the protocol or to complete standardizes questionaires\n* inability to receive contrast-enhanced planning CT\n* missing ability to give informed consent\n* legal custody",{"count":471,"type":20},100,"Prospective single arm, single center observational study to evaluate Quality of Life (Qol) after stereotactic body radiotherapy for patients with hepatocellular cancer. Patients will receive work-up, treatment and follow-up exclusively as routinely done except additional quality of life measurements. Qol will be measured by standardized and validated EORTC questionaires at different time points during routine follow-up.",[28,474,475,476],"Quality of Life","Stereotactic Body Radiation Therapy","Observational",[28,474,478,479],"stereotactic body radiation therapy","observational","2017-08-16",{"date":482,"type":34},"2017-08-18",{"date":484,"type":34},"2017-07-10",{"date":486,"type":20},"2027-07-10",{"name":488,"class":41},"Ludwig-Maximilians - University of Munich"]