[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-liver-cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-liver-cancers":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100402792","phase-1-a-study-evaluating-the-efficacy-and-safety-of-multiple-immunotherapy-based-treatment-combinations-in-patients-with-advanced-liver-cancers-morpheus-liver-100402792",false,"NCT04524871","A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)","A Phase Ib\u002FII, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)","MORPHEUS-LIVER","Inclusion Criteria:\n\nStage 1\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization\n* Locally advanced or metastatic and\u002For unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology\u002Fcytology or clinically by American Association for the Study of\n* Liver Diseases criteria in cirrhotic patients\n* Child-Pugh class A within 7 days prior to randomization\n* Disease that is not amenable to curative surgical and\u002For locoregional therapies\n* No prior systemic treatment for HCC\n* Life expectancy \\>= 3 months\n* Availability of a representative tumor specimen that is suitable for determination of PD-L1 and\u002For additional biomarker status via central testing\n\nStage 1 and Stage 2\n\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1\n* Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment\n* Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV)\n* Negative HIV test at screening\n* For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm\n\nStage 2\n\n* ECOG Performance Status of 0, 1, or 2\n* Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment\n* Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible)\n\nNKT2152-Containing Arm:\n\n* Total bilirubin ≤ 1.5 X ULN in the absence of Gilbert's disease (≤ 3.0 X ULN if Gilbert's disease)\n* AST\u002FALT ≤ 2.5 X ULN (≤ 5 X ULN if liver metastases present)\n\nExclusion Criteria:\n\nStage 1\n\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies or inhibitors targeting HIF2a\n* Treatment with investigational therapy within 28 days prior to initiation of study\n* Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure\n* Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or at high risk for bleeding\n* Prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study\n* AEs from prior anti-cancer therapy that have not resolved to Grade \\\u003C= 1 or better, with the exception of alopecia of any grade\n* Inadequately controlled hypertension\n* History of hypertensive crisis or hypertensive encephalopathy\n* Significant vascular disease\n* History of hemoptysis within 1 month prior to initiation of study\n* Evidence of bleeding diathesis or significant coagulopathy\n* Current or recent use of aspirin (\\>325 mg\u002Fday) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol\n* Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose\n* Core biopsy or other minor surgical procedure within 3 days prior to initiation of study\n* History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and\u002For clinical signs\u002Fsymptoms of GI obstruction\n* Evidence of abdominal free air not explained by paracentesis or recent surgery\n* Serious, non-healing\u002Fdehiscing wound, active ulcer, or untreated bone fracture\n* Grade \\>=2 proteinuria\n* Metastatic disease involving major airways\u002Fblood vessels, or centrally located mediastinal tumor masses of large volume\n* History of clinically significant intra-abdominal inflammatory process\n* Radiotherapy within 28 days or abdominal\u002Fpelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study\n* Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure\n* Chronic daily treatment with NSAID\n* Eligible only for control arm\n\nStage 1 and 2\n\n* Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC\n* History of hepatic encephalopathy\n* Moderate or severe ascites\n* HBV and HCV coinfection\n* Symptomatic, untreated, or actively progressing CNS metastases\n* History of leptomeningeal disease\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Uncontrolled or symptomatic hypercalcemia\n* Active or history of autoimmune disease or immune deficiency\n* History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n* Active TB\n* Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina\n* Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study\n* History of malignancy other than HCC within 5 years prior to screening\n* Severe infection within 4 weeks prior to initiation of study\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study\n* Prior allogeneic stem cell or solid organ transplantation\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known allergy or hypersensitivity to any of the study drugs or any of their excipients\n* Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study\n* Grade \\>= 3 hemorrhage or bleeding event within 8 weeks prior to initiation of study treatment\n* Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent","ALL","18 Years",{"count":20,"type":21},518,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a Phase Ib\u002FII, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.\n\nCohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.",[28],"Advanced Liver Cancers","RECRUITING","2026-06-17",{"date":32,"type":33},"2026-06-22","ACTUAL",{"date":35,"type":33},"2020-11-01",{"date":37,"type":21},"2027-09-30",{"name":39,"class":40},"Hoffmann-La Roche","INDUSTRY",33,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100446804","early-phase-1-a-study-of-gc101-til-in-advanced-hepatobiliary-pancreatic-cancers-10hospital-100446804","NCT05098197","A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital)","A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Hepatobiliary-Pancreatic Cancers","Inclusion Criteria:\n\n1. Age: 18 years to 75 years;\n2. Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized hepatobiliary cancer or pancreatic cancers;\n3. Expected life-span more than 3 months;\n4. Karnofsky≥60% or ECOG score 0-2;\n5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;\n7. At least 1 evaluable tumor lesion;\n8. Hematology and Chemistry（within 7 days prior to enrollment）:\n\n   * Absolute count of white blood cells≥2.5×10\\^9\u002FL;\n   * Absolute count of neutropils≥1.5×10\\^9\u002FL;\n   * Absolute count of lymphocytes ≥0.7×109\u002FL；\n   * Platelet count≥100×10\\^9；\n   * hemoglobin≥90 g\u002FL;\n   * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin;\n   * Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN);\n   * Totol bilirubin≤1.5×ULN;\n9. no absolute or relative contraindications to operation or biopsy;\n10. Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion；\n11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;\n12. Be able to understand and sign the informed consent document;\n13. Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;\n3. Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.\n4. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;\n5. Severe physical or mental diseases;\n6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);\n7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;\n8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;\n9. Having received immunotherapy and developed irAE level greater than Level 3;\n10. Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);\n11. Females in pregnancy or lactation;\n12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;\n13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.","75 Years",{"count":51,"type":21},50,[53],"EARLY_PHASE1","This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced hepatobiliary-pancreatic cancers. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.",[28,56,57,58,59],"Tumor Infiltrating Lymphocyte","Treatment Side Effects","Effects of Immunotherapy","Advanced Pancreatic Cancers","2025-12-04",{"date":62,"type":33},"2025-12-11",{"date":64,"type":33},"2021-09-26",{"date":66,"type":21},"2026-09-25",{"name":68,"class":40},"Shanghai Juncell Therapeutics",1]