[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatocellular-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatocellular-carcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,353,0,25,[9,63,89,113,135,162,191,222,262,285,320,352,374,401,421,449,480,499,530,555,599,625,644,663,691],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":40,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100639777","phase-1-a-first-in-human-study-of-hh160-in-patients-with-advanced-solid-tumors-100639777",false,"NCT07623369","A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors","An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria\n\n1. Adults aged 18 to 75 years with signed informed consent.\n2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.\n3. At least 1 measurable lesion per RECIST v1.1.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.\n5. Adequate organ function based on protocol-specified laboratory criteria.\n\nKey Exclusion Criteria\n\n1. Active leptomeningeal disease or uncontrolled\u002Funtreated brain metastases.\n2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.\n3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage\u002Fhemoptysis.\n\nNOTE: Other eligibility criteria may apply.","ALL","18 Years","75 Years",{"count":21,"type":22},299,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.",[28,29,30,31,32,33,34,35,36,37,38,39],"Solid Tumor","Non-small Cell Lung Cancer","Hepatocellular Carcinoma","Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Renal Cell Carcinoma","Endometrial Cancer","Cervical Cancer","Small-cell Lung Cancer","Triple Negative Breast Cancer","Urothelial Carcinoma","Gastroesophageal Adenocarcinoma",[41,42,29,43,30,44,31,45,46,32,33,47,34,35,36,37,48,38,39,49],"HH160","PD-1×CTLA-4×VEGF-A Antibody","NSCLC","HCC","CRC","GEA","RCC","TNBC","Ovarian Cancer","RECRUITING","2026-08-19",{"date":53,"type":54},"2026-08-21","ACTUAL",{"date":56,"type":54},"2026-06-11",{"date":58,"type":22},"2028-08",{"name":60,"class":61},"Huahui Health","INDUSTRY",3,{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100639337","scheduled-meditation-for-improving-postoperative-outcomes-in-patients-undergoing-pancreatectomy-100639337","NCT07608458","Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy","Scheduled Meditation for Perioperative Optimization: A Randomized Controlled Trial on Postoperative Outcomes, Pain, Anxiety, Insomnia, Stress, and Mobility in Pancreatectomy Patients","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Willing to install required apps on personal smartphone\n* Willing to wear a Garmin wearable device throughout the study\n* Age: ≥ 18 years\n* Ability to read and understand English for questionnaires\n* Owns a smartphone\n* Comfortable with routine smartphone use\n* Scheduled to undergo pancreatectomy\n\nExclusion Criteria:\n\n* Participants with prior formal training in meditation or mindfulness (e.g., completion of structured courses, workshops, or certification programs)\n* Participants who currently engage in a structured meditation or mindfulness practice, including regular use of mobile applications (e.g., Headspace, Calm, or similar platforms) or other formalized routines",{"count":71,"type":22},70,[73],"NA","This clinical trial tests the feasibility and how well a scheduled meditation intervention works to improve postoperative outcomes such as pain, anxiety, insomnia, stress and mobility for patients undergoing pancreatectomy. Many patients undergoing pancreatectomy surgery report clinically important fatigue, pain, and\u002For reduction in quality of life. Meditation is a behavioral intervention that has been studied in a variety of medical and surgical settings, where it has been associated with reductions in pain, anxiety, blood pressure, and lack of sleep, and in some cases with decreased pain and shorter length of stay. The meditation intervention using Headspace is an easily accessible and interactive way to complete scheduled meditation. This may improve postoperative outcomes for patients undergoing pancreatectomy.",[30,76,77],"Pancreas Cancer","Biliary Tract Neoplasms","NOT_YET_RECRUITING",{"date":80,"type":54},"2026-08-20",{"date":82,"type":22},"2026-10-01",{"date":84,"type":22},"2026-11-25",{"name":86,"class":87},"City of Hope Medical Center","OTHER",1,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":88},"100529778","phase-2-radiation-major-hepatectomy-to-selectively-treat-large-unifocal-hepatocellular-carcinoma-100529778","NCT06178198","Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma","An Open-label, Single-arm, Single-center Clinical Trial to Evaluate the Efficacy and Safety of Yttrium-90 Ablative Radioembolization (Radiation Major Hepatectomy) for Unifocal Large Hepatocellular Carcinoma","RESCUE","Inclusion Criteria:\n\n1. Adults aged 18 and over.\n2. Patients diagnosed with hepatocellular carcinoma histologically and\u002For radiologically (LI-RADS 4 or 5).\n3. Patients with no more than five lesions in dynamic contrast-enhanced CT or MRI, and the largest tumor diameter exceeding 8 cm.\n4. Patients without vascular invasion and bile duct invasion in dynamic contrast-enhanced CT or MRI.\n5. Patients with no extrahepatic metastasis in lung CT and contrast-enhanced abdominal CT or MRI.\n6. Patients with no prior treatment for liver cancer.\n7. Child-Pugh class A.\n8. ECOG performance status of 1 or less.\n9. Patients with no major organ dysfunction according to blood tests performed within one month of study enrollment.\n\n   1. Leukocytes ≥ 2,500\u002FµL and ≤ 12,000\u002FµL\n   2. Absolute neutrophil count ≥ 1,500 \u002Fmm\\^3\n   3. Hemoglobin ≥ 8.0 g\u002FdL (transfusion allowed to meet this criterion)\n   4. Total bilirubin ≤ 3.0 mg\u002FdL\n   5. Platelet ≥ 50,000\u002FµL\n   6. INR ≤ 2.0 for patients not taking anticoagulants\n   7. AST ≤ 200 IU\u002FL (i.e., ≤ 5X upper normal limit)\n   8. ALT ≤ 200 IU\u002FL (i.e., ≤ 5X upper normal limit)\n   9. ALP ≤ 575 IU\u002FL (i.e., ≤ 5X upper normal limit)\n   10. Creatinine ≤ 2.0 mg\u002FdL\n10. Patients with a life expectancy of more than 3 months.\n11. Patients who have adequately understood the clinical trial and consented in writing.\n12. Non-pregnant women of childbearing potential.\n\nExclusion Criteria:\n\n1. Patients who are not suitable for ablative radioembolization as indicated by pre-treatment testing with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.\n\n   1. Cases where the estimated lung dose exceeds 15 Gy when 150 Gy of absorbed dose is administered to the tumor based on the partition method.\n   2. Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments.\n2. Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume.\n3. Patients scheduled to use immunotherapy irrespective of the response to radioembolization.\n4. Patients who have had active cancer within the last two years prior to the clinical trial participation.\n5. Patients who have undergone surgery or procedures related to the bile duct.\n6. Women who are pregnant or breastfeeding.",{"count":98,"type":22},30,[100],"PHASE2","The RESCUE trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of ablative radioembolization using Yttrium-90. This treatment is being investigated as a potential curative approach, as well as a bridging or downstaging strategy for surgery, in patients with large hepatocellular carcinoma (greater than 8 cm) who maintain good liver function.",[30],[30,104],"Radioembolization","2026-08-18",{"date":80,"type":54},{"date":108,"type":54},"2023-11-08",{"date":110,"type":22},"2026-11-30",{"name":112,"class":87},"Seoul National University Hospital",{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100528884","phase-2-radioembolization-as-a-spearhead-treatment-of-hepatocellular-carcinoma-with-localized-portal-vein-tumor-thrombosis-100528884","NCT06166576","Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis","An Open-label, Prospective, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Ablative Radioembolization Using Yttrium-90 Glass Microspheres in Patients With Locally-advanced Hepatocellular Carcinoma","RESOLVE","Inclusion Criteria:\n\n1. Adults aged 18 and over\n2. Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and\u002For radiologically (LI-RADS 4 or 5)\n3. Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI\n4. Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI\n5. Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI\n6. Patients with no prior treatment for liver cancer\n7. Child-Pugh class A\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less\n9. Patients without serious dysfunction of major organs, as indicated by blood tests conducted within one month of study enrollment\n\n   1. Leukocytes ≥ 2,500\u002FµL and ≤ 12,000\u002FµL\n   2. Absolute neutrophil count ≥ 1,500\u002Fmm\\^3\n   3. Hemoglobin ≥ 8.0 g\u002FdL (transfusions allowed to meet this criterion)\n   4. Total bilirubin ≤ 3.0 mg\u002FdL\n   5. Platelets ≥ 50,000\u002FµL\n   6. For patients not on anticoagulants, INR ≤ 2.0\n   7. AST ≤ 200 IU\u002FL (i.e., ≤ 5X upper normal limit)\n   8. ALT ≤ 200 IU\u002FL (i.e., ≤ 5X upper normal limit)\n   9. ALP ≤ 575 IU\u002FL (i.e., ≤ 5X upper normal limit)\n   10. Creatinine ≤ 2.0 mg\u002FdL\n10. Patients with a life expectancy of more than 3 months\n11. Patients who have fully understood the clinical trial and given written consent\n12. Female patients of childbearing age confirmed not to be pregnant\n\nExclusion Criteria:\n\n1. Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.\n\n   1. Cases where, according to multi-compartment Medical Internal Radiation Dose method, delivering 205 Gy of radiation to the tumor exceeds an estimated lung dose of 25 Gy.\n   2. Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe.\n2. Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume.\n3. Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI.\n4. Patients scheduled to use immunotherapy regardless of the response to radioembolization.\n5. Patients who had active cancer within two years prior to joining the clinical trial.\n6. Patients who have undergone surgery or procedures related to the bile duct.\n7. Pregnant or breastfeeding women.",{"count":98,"type":22},[100],"The RESOLVE trial, an open-label, single-arm, multi-center study, aims to assess the efficacy and safety of ablative radioembolization using TheraSphere Yttrium-90 microspheres. This trial specifically targets patients diagnosed with hepatocellular carcinoma accompanied by localized portal vein tumor thrombosis (Vp1-Vp3) and who maintain good liver function.",[30],[126,104,127],"Hepatocellular carcinoma","Portal vein tumor thrombosis",{"date":80,"type":54},{"date":130,"type":54},"2023-11-20",{"date":132,"type":22},"2027-11-30",{"name":112,"class":87},5,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100574825","phase-1-a-first-in-human-study-to-learn-about-the-safety-of-bay-3547926-and-how-well-it-works-in-participants-with-advanced-liver-cancer-100574825","NCT06764316","A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer","A Multicenter, Open Label, Non-randomized First-in-human Phase 1 Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BAY 3547926 Alone, and in Combination, in Participants With Advanced Hepatocellular Carcinoma (HCC)","BANTAM-01","Inclusion Criteria:\n\n* Locally advanced or metastatic and\u002For unresectable HCC (hepatocellular carcinoma) with histological or cytological confirmation, or non-invasive diagnosis as per American Association for the Study of Liver Diseases (AASLD) criteria in participants with a confirmed diagnosis of cirrhosis.\n* Demonstrated positive centrally confirmed GPC3 expression by immunohistochemistry (IHC) on tumor sample.\n* Disease not amenable to, or progressive disease after, curative surgery and\u002For locoregional therapies of established efficacy such as resection, local ablation, chemoembolization.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* At least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. as assessed by local site Investigator within 28 days prior to the start of the study treatment.\n* Adequate bone marrow and organ function\n\nExclusion Criteria:\n\n* Fibrolamellar HCC, sarcomatoid HCC, and mixed hepatocellular\u002Fcholangiocarcinoma subtypes.\n* Participants with a history or clinical evidence of CNS metastases, unless they meet specific criteria\n* History of encephalopathy ≥ Grade 2 within the past 12 months\n* Clinically significant ascites",{"count":144,"type":22},148,[25],"In this study, researchers want to learn about the safety of a new drug, BAY 3547926, and how well the drug works in people with a type of liver cancer called advanced hepatocellular carcinoma (HCC), which has a special protein called Glypican 3 (GPC3). Researchers want to find the best dose of BAY 3547926 for people with advanced HCC and look at the way the body absorbs and distributes the drug.\n\nThe study drug, BAY 3547926, delivers a radioactive agent to cancer cells. The radioactive agent emits radiations which can damage the cancer cells and cause them to die. These radiations travel a small distance, so are expected to cause little damage to surrounding healthy tissues. This is the first study of BAY 3547926 in humans.\n\nParticipants will take part in one of the 4 different parts of the study. In Part 1, participants will receive different doses of BAY 3547926 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3547926 alone in Part 2 or with other treatments in Parts 3 and 4 of the study.\n\nDuring the study, the doctors and their study team will do health check-ups, take pictures (scans) of the body, collect blood and urine samples, and ask participants questions about how they are feeling and what health problems they are having.",[30],[149,150,151,152],"Hepatocellular carcinoma (HCC)","Locally advanced HCC","Metastatic HCC","Unresectable HCC","2026-08-17",{"date":105,"type":54},{"date":156,"type":54},"2025-02-28",{"date":158,"type":22},"2031-08-31",{"name":160,"class":61},"Bayer",24,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":180,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100610394","phase-1-symbiotic-gi-13-a-study-to-learn-about-study-medicine-called-pf-08634404-as-a-single-treatment-and-combination-treatment-in-adult-participants-with-a-liver-cancer-called-hepatocellular-carcinoma-that-is-too-advanced-to-be-removed-by-surgery-and-may-have-spread-to-other-parts-of-the-body-100610394","NCT07227012","Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.","AN INTERVENTIONAL OPEN-LABEL PHASE 1B\u002F2 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 AS MONOTHERAPY AND COMBINATION THERAPY IN ADULT PARTICIPANTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Locally advanced or metastatic HCC with diagnosis confirmed by histology\u002Fcytology or clinically by AASLD criteria (for patients with cirrhosis). Participants without cirrhosis require histological confirmation of diagnosis.\n* Disease that is not amenable to curative surgical and\u002For locoregional therapies, or progressive disease after surgical and\u002For locoregional therapies.\n* At least 1 measurable (as defined by RECIST 1.1 per investigator) and untreated lesion.\n* Adequate hepatic, liver, and renal function\n* No prior systemic therapy for HCC.\n* ECOG performance status 0 or 1\n* Child-Pugh Class A\n\nKey Exclusion Criteria:\n\n* Moderate or severe ascites.\n* History of hepatic encephalopathy.\n* Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.\n* Clinically significant risk of hemorrhage or fistula.\n* Participants with any history of another malignancy within 3 years.\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years.\n* Clinically significant cardiovascular disease within 6 months prior to the first dose.\n* Major surgery or severe trauma within 4 weeks prior to the first dose or planned major surgery during the study.\n* History of severe bleeding tendency or coagulation dysfunction.\n* History of severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, including bleeding event due to esophageal and\u002For gastric varices, within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections.\n* Participants with history of immunodeficiency.",{"count":170,"type":22},138,[25,100],"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.",[174,175,30,176,177,178,179],"Carcinoma, Hepatocellular","Hepatocellular Cancer","Unresectable Hepatocellular Carcinoma","Liver Neoplasms","Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma",[30,181,177],"Liver cancer","2026-08-14",{"date":153,"type":54},{"date":185,"type":54},"2025-12-01",{"date":187,"type":22},"2028-10-17",{"name":189,"class":61},"Pfizer",54,{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100577186","phase-1-first-in-human-study-to-evaluate-azd9793-in-participants-with-advanced-or-metastatic-solid-tumours-100577186","NCT06795022","First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours","A Modular Phase I\u002FII Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD9793, a T Cell-engaging Antibody Targeting Glypican-3 (GPC3) in Adult Participants With Advanced or Metastatic Solid Tumours (RHEA-1)","RHEA-1","Key Inclusion Criteria:\n\n* Age ≥ 18 at the time of signing the informed consent.\n* GPC3 positive tumour as determined by a central laboratory using an analytically validated IHC assay. Patients who previously received any therapy targeting GPC3 must undergo central laboratory GPC3 testing on tumour tissue collected after completion of the prior GPC3-targeted therapy.\n* Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening.\n* Predicted life expectancy of ≥ 12 weeks.\n* Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol.\n* Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol.\n* Confirmed advanced recurrent and\u002For metastatic and\u002For unresectable HCC, which is histopathologically proven based on the criteria established by the World Health Organization.\n* Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.\n* Child-Pugh Score class A.\n* Previous therapy:\n\nPart A: Patients who have received at least one prior line of standard systemic therapy for HCC as per National Comprehensive Cancer Network or other local scientific guidelines and for which a clinical study is the best option for next treatment based on prior response and\u002For tolerability and\u002For patient\u002Finvestigator decision.\n\nPart B: Patients must not have received more than one prior line of systemic therapy in the advanced recurrent and\u002For metastatic setting.\n\nKey Exclusion Criteria:\n\n* Unresolved toxicity from prior anticancer therapy, including imAEs, of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for vitiligo, peripheral neuropathy related to prior anti-cancer therapy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities.\n* Prior to enrolment, participation in another clinical study with an investigational product administered in the last 21 days or 5 half-lives whichever is shorter.\n* CAR-T cell therapy within the last 6 months prior to enrolment on this study.\n* Known allergy or hypersensitivity to AZD9793 or any of the excipients of the product as outlined in the IB.\n* Requires chronic immunosuppressive therapy (including steroids \\> 10 mg prednisone\u002Fday or equivalent).\n* Received radiation within 14 days prior to first dose of study treatment; palliative radiation to reduce the risk of tumour lysis syndrome (TLS) or CRS\u002Fneurotoxicity in participants with bulky disease is permitted.\n* Undergone a major surgical procedure within 14 days prior to first dose of study treatment days to allow adequate healing\n* Experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy.\n* Previous history of hemophagocytic lymphohistiocytosis (HLH) \u002F macrophage activation syndrome (MAS).\n* Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment.\n* Cardiac conditions as defined by the protocol.\n* History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention.\n* Central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent.\n* Infectious disease including active human immunodeficiency virus (HIV), and uncontrolled active systemic fungal, bacterial or other infection.\n* Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular malignant cholangiocarcinoma.",{"count":200,"type":22},304,[25,100],"This research is designed to determine if experimental treatment with AZD9793, a T cell-engaging antibody that targets GPC3, is safe, tolerable and has anti-cancer activity in patients with advanced or metastatic solid tumours which are GPC3+.",[30],[205,206,207,208,209,210,211,44],"Glypican-3","GPC3","GPC3+ tumours","T cell-engaging antibody","TCE","AZD9793","Solid tumours","2026-08-12",{"date":214,"type":54},"2026-08-13",{"date":216,"type":54},"2025-03-27",{"date":218,"type":22},"2028-06-30",{"name":220,"class":61},"AstraZeneca",21,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":232,"studyType":233,"phases":4,"briefSummary":234,"conditions":235,"keywords":240,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":4},"100651885","prospective-evaluation-of-hepatocellular-carcinoma-surveillance-in-at-risk-patients-screening-hcc-100651885","NCT07764835","Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients (Screening HCC)","Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients Using Semiannual Ultrasound LI-RADS and Alpha-Fetoprotein: A Multicenter Real-World Observational Study","Screening HCC","Inclusion Criteria:\n\n* Written informed consent.\n* Age 18 years or older.\n* Liver cirrhosis of any etiology.\n* Chronic hepatitis B with moderate or high risk of HCC according to PAGE-B criteria.\n* Non-cirrhotic chronic liver disease with increased risk for HCC, including fibrosis stage 3 or higher or metabolic dysfunction-associated steatotic liver disease (MASLD) with one or more risk factors for HCC.\n* Followed at hepatology clinics within the Rede D'Or health network.\n* Eligible for routine HCC surveillance with ultrasound and alpha-fetoprotein according to standard clinical practice.\n\nExclusion Criteria:\n\n* Known hepatocellular carcinoma at enrollment.\n* Previous diagnosis of hepatocellular carcinoma.\n* Metastatic liver disease.\n* Other malignant liver tumors present at enrollment.\n* Clinical condition preventing routine surveillance follow-up.\n* Inability to provide informed consent.",{"count":231,"type":22},300,"36 Months","OBSERVATIONAL","This prospective multicenter observational study evaluates the performance of a structured hepatocellular carcinoma (HCC) surveillance program in patients at increased risk of developing liver cancer. Participants will undergo routine surveillance with semiannual abdominal ultrasound reported using the Ultrasound Liver Imaging Reporting and Data System (US LI-RADS) and serum alpha-fetoprotein (AFP) testing as part of standard clinical care. The study aims to assess HCC detection rates, stage at diagnosis, detection of other hepatic malignancies, and the time intervals between detection, diagnosis, and treatment in a real-world setting. Approximately 300 participants will be enrolled and followed for up to 36 months.",[30,236,237,238,239],"Liver Cirrhosis","Chronic Hepatitis B","Metabolic Dysfunction-Associated Steatotic Liver Disease","Advanced Liver Fibrosis",[44,30,241,242,243,244,245,246,236,237,247,238,248,249,250,251,252,253],"Liver Cancer","HCC Surveillance","US LI-RADS","Ultrasound LI-RADS","Alpha-Fetoprotein","AFP","MASLD","Real-World Study","Observational Study","Early Detection","BCLC","Rede D'Or","Brazil","2026-08-10",{"date":182,"type":54},{"date":257,"type":22},"2026-09-15",{"date":259,"type":22},"2029-06-30",{"name":261,"class":87},"D'Or Institute for Research and Education",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":284},"100583761","phase-2-stride-durvalumab--tremelimumab-with-lenvatinib-vs-stride-alone-in-unresectable-hepatocellular-carcinoma-100583761","NCT06880523","STRIDE (Durvalumab + Tremelimumab) With Lenvatinib vs STRIDE Alone in Unresectable Hepatocellular Carcinoma","A Phase II Study of STRIDE (Durvalumab + Tremelimumab) With Lenvatinib Versus STRIDE Alone in Patients With Unresectable Hepatocellular Carcinoma (SLIDE-HCC)","SLIDE-HCC","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Body weight \\> 30 kg.\n* Life expectancy of at least 12 weeks.\n* Confirmed HCC based on histopathological findings from tumour tissues or clinically by AASLD criteria in cirrhotic participants.\n* Must not have received prior systemic therapy for HCC.\n* Must not be eligible for locoregional therapy for unresectable HCC. For patients who progressed after locoregional therapy for HCC, locoregional therapy must have been completed ≥28 days prior to the baseline scan of the abdomen and pelvis for the current study.\n* Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.\n* Child-Pugh Score class A or B7 based on low albumin (albumin 25-27 g\u002FL) only.\n* Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines. A lesion which progressed after previous ablation or TACE could be measurable if it meets these criteria.\n* Participants with active HBV infection \\[characterized by positive hepatitis B virus surface antigen (HBsAg) and\u002For positive hepatitis B core antibodies (anti-HBcAb) with detectable HBV deoxyribonucleic acid (DNA) (≥10 IU\u002FmL or above the limit of detection per local lab standard)\\] are eligible if:\n* The participant is being treated with antiviral therapy, as per institutional practice. The HBV antiviral therapy must be initiated prior to randomization, and the participant must remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication.\n* The participant must show evidence of HBV stabilization or signs of viral response (eg, reduction of HBV DNA levels) prior to enrollment\n* Participants who test positive for HBsAg or anti-hepatitis B core (HBc) with undetectable HBV DNA (\\\u003C 10 IU\u002FmL or under the limit of detection per local lab standard) are eligible and do not require antiviral therapy prior to randomization.\n* These participants will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥ 10 IU\u002FmL or above the limit of detection per local lab standard).\n* If HBV DNA becomes detectable during study treatment, antiviral therapy must be initiated, and the participant must remain on antiviral therapy during the study treatment period and for 6 months after the last dose of study medication.\n* Participants with active HCV infection (as characterized by the presence of detectable HCV ribonucleic acid \\[RNA\\] or anti-HCV antibody \\[anti-HCV\\]) must be managed per local institutional practice for the study and for 6 months after the last dose of study treatment.\n* Adequate organ and marrow function, within 14 days prior to enrollment.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method from enrollment to 90 days after the last dose of durvalumab or 180 days after the last dose of tremelimumab (whichever date is later).\n* Participants must agree not to donate blood for at least 90 days following the last infusion of durvalumab or tremelimumab, or until 7 days after the last dose of lenvatinib, whichever is longest.\n\nExclusion Criteria:\n\n* Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other tumours curatively treated with no evidence of disease for ≥ 5 years.\n* Any concurrent chemotherapy, study drug, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n* Known fibrolamellar HCC, sarcomatoid HCC, infiltrative-type HCC or mixed cholangiocarcinoma and HCC.\n* Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention\n* Uncontrolled arterial hypertension defined by a systolic pressure ≥ 150 mm Hg or diastolic pressure ≥ 90 mm Hg or other hypertensive cardiovascular complications despite standard medical management.\n* Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab, or an anti-CTLA4, including tremelimumab.\n* History of primary immunodeficiency, history of organ transplant or prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.\n* Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n* Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab\n* Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\n* Patients with active or uncontrolled intercurrent illness\n* History of leptomeningeal carcinomatosis.\n* Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and\u002For corticosteroids.\n* Major surgical procedure (as defined by the Investigator) within 28 days prior to enrollment.\n* 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).\n* Receipt of live attenuated vaccination (examples include, but are not limited to, vaccines for measles, mumps, and rubella, live attenuated influenza vaccine (nasal), chicken pox vaccine, oral polio vaccine, rotavirus vaccine, yellow fever vaccine, BCG vaccine, typhoid vaccine and typhus vaccine) within 30 days prior to enrollment.\n* Lactating participants.\n* Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.\n* Receipt of radiotherapy within four weeks of first planned dose of durvalumab or tremelimumab, except for a single dose of radiation up to 8 Gray (equal to 800 RAD) delivered with palliative intent for pain control up to 14 days before enrollment.\n* Active or prior documented GI bleeding (e.g. esophageal varices or ulcer bleeding) within 6 months. (Note: For patients with a history of GI bleeding more than 6 months prior or assessed as high risk for esophageal varices by the Investigator or main trunk portal vein thrombosis (Vp4), adequate endoscopic assessment and treatment of varices as per institutional standards is required prior to enrollment.)",{"count":271,"type":22},140,[100],"The purpose of this study is to compare the effects on participants' and liver cancer by adding a drug that is used on its own to treat this disease to a combination of two other drugs which is also used to treat liver cancer, compared to the two-drug combination alone.",[30],{"date":276,"type":54},"2026-08-11",{"date":278,"type":54},"2025-10-21",{"date":280,"type":22},"2028-12-31",{"name":282,"class":283},"Canadian Cancer Trials Group","NETWORK",13,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":319},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":293,"type":22},250,[25],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[297,298,299,300,301,36,302,303,34,304,305,35,31,306,307,76,308,30,309,310,49,311],"Advanced Solid Tumor","Advanced Cancer","Metastatic Cancer","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Bladder Cancer","Sarcoma","Melanoma","Castration Resistant Prostatic Cancer","Gastric Cancer","Gastro-esophageal Cancer","Clear Cell Renal Cell Carcinoma","Platinum-resistant Ovarian Cancer","Breast Cancer","Esophageal Squamous Cell Cancer (SCC)",{"date":276,"type":54},{"date":314,"type":54},"2024-03-06",{"date":316,"type":22},"2028-10",{"name":318,"class":61},"MacroGenics",12,{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":328,"targetDuration":4,"studyType":23,"phases":330,"briefSummary":331,"conditions":332,"keywords":336,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":350,"locationsCount":88},"100651415","68ga-sorb-petct-imaging-in-patients-with-solid-tumors-100651415","NCT07760012","68Ga-SorB PET\u002FCT Imaging in Patients With Solid Tumors","A Prospective, Single-Center, Open-Label Exploratory Study of 68Ga-SorB PET\u002FCT Imaging for the Diagnosis of Sortilin-Positive Solid Tumors","SORB-PET","Inclusion Criteria:\n\n* \\- Adults aged 18 to 75 years.\n* Histologically confirmed or clinically suspected melanoma, hepatocellular carcinoma, lung cancer, breast cancer, pancreatic cancer, or ovarian cancer.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, renal, and coagulation function:\n* White blood cell count ≥ 4.0 × 10\\^9\u002FL or absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL;\n* Platelet count ≥ 100 × 10\\^9\u002FL;\n* Hemoglobin ≥ 90 g\u002FL;\n* PT or APTT ≤ 1.5 × upper limit of normal (ULN);\n* Total bilirubin ≤ 1.5 × ULN;\n* ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN for participants with liver metastases);\n* ALP ≤ 2.5 × ULN (or ≤ 4.5 × ULN for participants with bone or liver metastases);\n* Blood urea nitrogen and serum creatinine ≤ 1.5 × ULN.\n* Normal cardiac function.\n* Estimated life expectancy of at least 12 weeks.\n* Willing and able to comply with study procedures and follow-up.\n* At least one measurable target lesion according to RECIST version 1.1.\n* Participants of childbearing potential agree to use effective contraception during the study and for 3 months after PET\u002FCT imaging.\n* Clinically indicated to undergo 18F-FDG PET\u002FCT for tumor evaluation.\n* Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Severe dysfunction of major organs (including heart, liver, or kidney) that, in the investigator's judgment, would make participation inappropriate.\n* Inability to tolerate PET\u002FCT imaging or complete study follow-up.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.",{"count":329,"type":22},50,[73],"This prospective, single-center, open-label exploratory diagnostic study aims to evaluate the safety, feasibility, and diagnostic performance of the novel Sortilin-targeted PET tracer 68Ga-SorB in patients with solid tumors. Eligible participants with confirmed or suspected melanoma, hepatocellular carcinoma, lung cancer, pancreatic cancer, breast cancer, or ovarian cancer will undergo 68Ga-SorB PET\u002FCT imaging. The imaging findings will be compared with standard-of-care 18F-FDG PET\u002FCT, using pathology results and\u002For clinical follow-up as the reference standard.\n\nThe primary objectives are to evaluate the safety and tolerability of 68Ga-SorB, assess imaging feasibility, and characterize tumor uptake using quantitative PET parameters, including SUVmax and tumor-to-background ratio (TBR). Secondary exploratory objectives include comparing lesion detection between 68Ga-SorB PET\u002FCT and 18F-FDG PET\u002FCT, assessing diagnostic sensitivity and specificity, evaluating imaging characteristics across different tumor types, and exploring the correlation between Sortilin expression and tracer uptake. This study will provide preliminary clinical evidence supporting the development of Sortilin-targeted molecular imaging and future theranostic applications.",[333,30,334,310,335,49],"Melanoma (Skin Cancer)","Lung Cancer","Pancreatic Cancer",[337,338,339,340,341,342,343,344],"Sortilin","68Ga-SorB","PET\u002FCT","Molecular Imaging","Diagnostic Imaging","Positron Emission Tomography","Radiotracer","Oncology","2026-08-09",{"date":212,"type":54},{"date":348,"type":22},"2026-07-24",{"date":280,"type":22},{"name":351,"class":87},"Peking University Third Hospital",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":88},"100558339","the-effect-of-nutrition-optimized-prehabilitation-on-perioperative-intervention-in-primary-hepatocellular-carcinoma-100558339","NCT06549829","the Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Liver Carcinoma","Nutrition-Optimized Prehabilitation's Impact on Perioperative Outcomes in Primary Liver Carcinoma: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients diagnosed with primary liver cancer.\n\n  * Patients between the ages of 18 and 80.\n\n    * Patients who are feasible for surgical treatment after clinical evaluation.\n\nExclusion Criteria:\n\n* Patients with liver metastases or combined with other tumors.\n\n  * Patients with allergy to the ingredients of nutritional preparations. ③Patients with severe malnutrition who cannot eat by mouth. ④Patients with hyperthyroidism, fistula, and combined digestive system diseases.","80 Years",{"count":361,"type":22},120,[73],"The aim of this project is to investigate the effect of triple prehabilitation led by nutritional optimization in liver cancer patients' surgery. It improves the preoperative nutritional status of cancer patients, reduces the incidence of early postoperative complications, promotes postoperative recovery, and improves the quality of patients' survival. Patients were randomized into experimental and control groups based on exclusion and inclusion criteria. Nutritional interventions and exercise and psychological interventions for patients. Routine clinical blood tests will be performed at the time of enrollment, on the first day before surgery and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1 month postoperatively.",[30,365,366],"Liver Carcinoma","Hepatobiliary Cancers",{"date":212,"type":54},{"date":369,"type":54},"2024-09-01",{"date":371,"type":22},"2026-10-31",{"name":373,"class":87},"Second Affiliated Hospital, Zhejiang University, School of Medicine",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":389,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":88},"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":383,"type":22},40,[73],"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.",[241,30,175,387,388],"Cholangiocarcinoma","Liver Metastases",[390,391,392],"Blood-based biomarkers","Quantitative MR imaging","Radiotherapy","2026-08-07",{"date":276,"type":54},{"date":396,"type":54},"2025-07-16",{"date":398,"type":22},"2031-07",{"name":400,"class":87},"Montefiore Medical Center",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":359,"enrollmentInfo":408,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":88},"100605171","the-safety-efficacy-and-immune-response-of-multimodal-thermal-therapy-in-the-treatment-of-malignant-liver-tumors-100605171","NCT07159048","The Safety, Efficacy, and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors","A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Safety, Efficacy and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors","Inclusion Criteria:\n\n1. Age of 18-80 years.\n2. Clinical diagnosis or pathologic of hepatocellular carcinoma (HCC) or metastatic liver cancers.\n3. Intrahepatic lesions with a diameter of ≤5cm, and the number of lesions ≤5.\n4. Without extrahepatic metastases; for patients with liver metastases, previously underwent radical resection of the primary lesion without local recurrence.\n5. Child-Pugh score ≤7 (Class A or B).\n6. Performance status 0-1 (Eastern Cooperative Oncology Group classification).\n7. Life expectancy of at least 3 months.\n8. Patients who have previously undergone surgery, chemotherapy, targeted therapy, ablation, vascular interventional therapy (TACE, D-TACE, HAIC), or immunotherapy, with an interval of ≥3 weeks since the last treatment.\n9. The functional level of major organs must meet the following requirements:\n\n(1) Blood Routine: WBC≥3.0×109\u002FL，ANC≥1.5×109\u002FL，PLT≥50×109\u002FL，HGB≥90 g\u002FL. (2) Liver Function: AST ≤5.0×ULN, ALT ≤5.0×ULN, TBIL ≤2.0×ULN. (3) Renal Function: Cr ≤1.5×ULN or CrCl ≥60 mL\u002Fmin. (4) Coagulation Function: INR ≤1.5; APTT ≤1.5×ULN. (5) HBV-DNA: HBV-DNA ≤2×10³ IU\u002FmL (\\*Patients with HBV-DNA \\>2×10³ IU\u002FmL may be enrolled but must receive antiviral therapy.\\*)\n\nExclusion Criteria:\n\n1. Diffuse hepatocellular carcinoma (HCC), or with tumor thrombus in the main portal vein to secondary branches or hepatic veins.\n2. Severe liver atrophy or excessively large tumor volume requiring ablation of ≥1\u002F3 of the liver volume.\n3. Uncorrectable coagulation dysfunction or severe hematologic abnormalities with a high risk of bleeding.\n4. Active bacterial infection or fungal infection.\n5. Previous or coexisting malignancies.\n6. History of solid organ transplant or hepatic encephalopathy.\n7. Current enrollment in another clinical trial or prior exposure to experimental therapies.\n8. Pregnant or breastfeeding, or preparing to pregnant.\n9. Not suitable to participate in clinical trials judged by investigator.",{"count":361,"type":22},[73],"Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. The feasibility and safety for MTT in the treatment of malignant liver tumors is well-established. This prospective, multi-center, randomized controlled clinical study aimed to explore the ablation-induced immune activating response of MTT in the treatment of malignant liver tumors.",[30,412],"Colorectal Cancer Liver Metastasis","2026-08-06",{"date":254,"type":54},{"date":416,"type":54},"2025-10-15",{"date":418,"type":22},"2027-10-31",{"name":420,"class":87},"Fudan University",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":17,"minAge":428,"maxAge":429,"enrollmentInfo":430,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":432,"conditions":433,"keywords":439,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":88},"100359417","molecular-basis-of-pediatric-liver-cancer-100359417","NCT03959800","Molecular Basis of Pediatric Liver Cancer","Genetic and Molecular Basis of Pediatric Liver Cancer","Inclusion Criteria:\n\n* Prior or current treatment for a childhood liver tumor, malignant or benign, at age \\\u003C21 years.\n* Biological parents and siblings of eligible children.\n\nExclusion Criteria:\n\n* No prior or current treatment for a childhood liver tumor.\n* Non-biological parents, legal guardians, or non-biological siblings of eligible children.","0 Years","99 Years",{"count":431,"type":22},1600,"The purpose of this retrospective and prospective project is to understand the molecular and genetic basis of liver cancer of childhood. Understanding the molecular and genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.",[434,435,436,437,30,438],"Childhood Liver Cancer","Liver Malignant Tumors","Embryonal Sarcoma of Liver (Disorder)","Hepatoblastoma","Rhabdoid Tumor of Liver",[437,30,440],"Pediatric Liver Cancer","2026-08-05",{"date":254,"type":54},{"date":444,"type":54},"2015-06-22",{"date":446,"type":22},"2035-06-30",{"name":448,"class":87},"University of Pittsburgh",{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":23,"phases":458,"briefSummary":459,"conditions":460,"keywords":466,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":134},"100586075","phase-1-idov-immune-for-advanced-solid-tumors-100586075","NCT06910657","IDOV-Immune for Advanced Solid Tumors","A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapy, or for which no standard therapy exists.\n* ECOG performance status ≤ 1.\n* Measurable disease per RECIST v1.1.\n* Adequate organ and bone marrow function.\n* At least 28 days since major surgery, prior immunotherapy, or radiotherapy (with exceptions for minor procedures).\n* Negative pregnancy test for women of childbearing potential.\n* Agreement to use effective contraception during treatment and for 3 months after.\n* Ability to provide informed consent and comply with study requirements.\n\nKey Exclusion Criteria:\n\n* Prior treatment with an oncolytic virus.\n* Active or recent vaccinia virus infection or smallpox\u002Fmonkeypox vaccination within 10 years.\n* Active uncontrolled infection requiring systemic treatment.\n* History of hepatitis B, hepatitis C, or HIV (unless meeting protocol-specific criteria).\n* Unresolved ≥ Grade 2 toxicities from prior therapies (except hair loss or stable chronic conditions).\n* Active or symptomatic autoimmune disease requiring systemic therapy.\n* Active or untreated CNS metastases (unless stable per protocol).\n* Significant cardiac disease (e.g., NYHA Class III\u002FIV heart failure).\n* Interstitial lung disease or prior pneumonitis requiring steroids.\n* Conditions requiring chronic immunosuppressive therapy.\n* Severe skin disorders or history of pancreatitis.\n* Bleeding disorders or history of recent serious thromboembolic events.\n* Any medical or psychiatric condition that could interfere with study participation.",{"count":457,"type":22},78,[25],"This is a Phase I clinical trial evaluating an investigational treatment called IDOV-Immune, a type of oncolytic virus therapy, for adults with advanced solid tumors that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight the tumor.\n\nThe purpose of this study is to determine the safety of IDOV-Immune, how well it is tolerated, and to identify the highest dose that can be safely given. Researchers will also study how the drug behaves in the body, how the immune system responds to it, and whether it shows any signs of shrinking tumors.\n\nParticipants will receive a single intravenous (IV) infusion of IDOV-Immune and will be closely monitored for side effects and any changes in their cancer.\n\nThis study is being conducted at multiple sites in the United States and Australia.",[31,335,304,49,306,461,30,33,310,303,302,334,462,463,464,465],"Esophageal Cancer","Prostate Cancer","Cervical Cancers","Head and Neck Cancers","Adrenal Gland Tumors",[467,468,299,469,470,471],"Oncolytic Virus Therapy","Advanced Solid Tumors","Refractory Cancer","Immunotherapy","Vaccinia Virus","2026-08-03",{"date":441,"type":54},{"date":475,"type":54},"2025-08-25",{"date":477,"type":22},"2027-05-31",{"name":479,"class":61},"ViroMissile, Inc.",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":23,"phases":489,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":497,"locationsCount":88},"100606772","phase-2-radiotherapy-combined-with-ql1706-and-bevacizumab-for-unresectable-non-metastatic-hepatocellular-carcinoma-100606772","NCT07179900","Radiotherapy Combined With QL1706 and Bevacizumab for Unresectable Non-metastatic Hepatocellular Carcinoma","Exploration of Radiotherapy Combined With QL1706 and Bevacizumab for the Conversion Treatment of Unresectable Non-metastatic Hepatocellular Carcinoma: A Prospective, Open-label, Randomized Controlled Clinical Study","Inclusion Criteria:\n\nAge ≥ 18 years old, gender not limited; PS score 0-2; Pathologically or clinically diagnosed as primary HCC and has not received other anti-HCC treatment; No history of other malignant tumors or treatment; Patients with BCLC stage B or C before treatment and no distant metastasis, and surgical assessment indicates that first-line surgical resection is not feasible; Liver function grade Child-Pugh A or B ≤ 7 points; For patients with active HBV infection, antiviral treatment should be initiated at least 7 days before treatment and they should agree to continue antiviral treatment during the study period; No severe cardiovascular or cerebrovascular diseases; Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the treatment period and 6 months after treatment; if the serum or urine pregnancy test is negative within 14 days before inclusion in the study, and the patient must be non-lactating; men should agree to take contraceptive measures during the study period and 6 months after the study; Voluntarily sign the written informed consent form and commit to comply with the protocol during the study period, including accepting treatment and scheduled visits and examinations, including follow-up; The expected survival must be at least 12 weeks.\n\nExclusion Criteria:\n\nPatients who do not meet the above main inclusion criteria; Patients who refuse to sign the informed consent form; Patients with pathological types of cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar cell carcinoma; or those with postoperative pathology suggesting metastatic cancer or primary cancer of other tissue types; Patients with portal hypertension diagnosed by preoperative enhanced abdominal CT and endoscopy, with a history of esophageal variceal bleeding, severe hypersplenism syndrome or refractory ascites; Patients diagnosed with severe active scleroderma, lupus, other rheumatic diseases or autoimmune diseases within the past 3 months before study recruitment; patients with a history of clinically severe autoimmune diseases or those requiring systemic steroids or immunosuppressants will not be allowed to participate in this study; Patients with a history of cognitive dysfunction or mental illness that affects treatment compliance; Patients whom the investigator deems unsuitable for participation in this study.",{"count":488,"type":22},60,[100],"This project is a prospective, open-label, randomized controlled clinical study. It plans to enroll 60 patients with unresectable HCC and no distant metastasis, randomly assigned to the experimental group and the control group, with 30 cases in each group. The experimental group was treated with radiotherapy combined with immunotherapy and Bevacizumab, while the control group was treated with immunotherapy and Bevacizumab. The efficacy of the patients and the conversion rate to surgery were evaluated.",[30],"2026-07-31",{"date":472,"type":54},{"date":495,"type":54},"2025-03-01",{"date":316,"type":22},{"name":498,"class":87},"Hebei Medical University Fourth Hospital",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":516,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":529},"100473299","targeted-therapy-drug-monitoring-in-digestive-oncology-100473299","NCT05443087","TARGETed Therapy Drug MONITOring in DIGestive Oncology","Dosing of Various Multi Kinases Inhibitors Plasma Concentrations for Patients Treated for Their Advanced Digestive Cancer, With the Aim to Determine the Best Optimal Dose for Each Treatment, in the Future","TARGETMONITO","Inclusion Criteria:\n\n1. Patient aged 18 years or over\n2. Advanced digestive cancer (histologically confirmed or confirmed by imaging for HCC) for which a standard treatment (according to each drug SmPC and as per standard of care) planned with:\n\n   * Regorafenib for GIST, mCRC, and HCC,\n   * Everolimus for gepNET,\n   * Sunitinib for pNET or GIST,\n   * Cabozantinib for HCC,\n   * Encorafenib - cetuximab for mCRC\n3. Life expectancy of greater than 3 months - at the discretion of the investigator\n4. Measurable disease according to tumor evaluation criteria as per local practice (Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, etc.)\n5. Patients must be affiliated to a Social Security System (or equivalent)\n6. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n\nExclusion Criteria:\n\n1. Other concomitant anticancer systemic treatment (chronic chemotherapy, antitumor hormone therapy or immunotherapy) than the one studied\n2. Unresolved toxicity higher than NCI-CTCAE v5.0 Grade 1 attributed to any prior therapy\u002Fprocedure excluding alopecia and peripheral neuropathy\n3. Prior treatment with the same MKI molecule(s) planned to be given in the cohort. If different MKI molecules (from the one(s) planned in the study) have been previously taken, a wash out period of 2 weeks before treatment should be observed.\n4. Other invasive malignancies either currently active or active in the last 3 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell carcinoma of the skin\n5. Any condition that may jeopardize patient participation in the study as well as non contraception for male and female with child-bearing potential, pregnancy or breast feeding.\n6. Patient unwilling or unable to comply with the medical follow-up required by the standard treatment taken (including PK sampling during treatment phase and vital status collection during follow-up phase) because of psychosocial, familial, social or geographical reasons\n7. Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion and during the present study (except if patient is included in the control arm, with placebo or with a product which have a marketed authorisation, used as per the SmPC for the given indication)\n8. Patient deprived of their liberty or under protective custody or guardianship",{"count":508,"type":22},330,[73],"Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), or pancreatic neuroendocrine tumor (pNET)), with the aim of determine the optimal dose adapted for each patient, in the future.",[512,513,30,514,515],"Digestive Cancer","Metastatic Colorectal Cancer","GIST","Neuroendocrine Tumors",[517,518,519,520,521],"multi kinases inhibitors","therapeutic drug monitoring","pharmacokinetics","pharmacodynamics","advanced digestive cancers",{"date":472,"type":54},{"date":524,"type":54},"2022-08-29",{"date":526,"type":22},"2027-06",{"name":528,"class":87},"UNICANCER",29,{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":537,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":539,"briefSummary":540,"conditions":541,"keywords":543,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":553,"locationsCount":88},"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":488,"type":22},[100],"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).",[30,175,31,542,388],"Colorectal Carcinoma",[544,545,546,31,175,470,547],"Tumour neoantigens","Tumor neoantigens","Cancer vaccine","anti-PD1","2026-07-30",{"date":492,"type":54},{"date":551,"type":54},"2021-04-15",{"date":526,"type":22},{"name":554,"class":87},"National Cancer Centre, Singapore",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":88},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":563,"type":22},27,[100],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[567,568,569,570,571,572,542,573,574,575,576,577,578,30,579,580,581,582,304,583,584,585,586,587,588,589,33,590,38],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lung Carcinoma","Malignant Solid Neoplasm","Mantle Cell Lymphoma","Merkel Cell Carcinoma","Multiple Myeloma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Squamous Cell Carcinoma","2026-07-28",{"date":548,"type":54},{"date":594,"type":54},"2025-12-18",{"date":596,"type":22},"2026-12-18",{"name":598,"class":87},"Mayo Clinic",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":23,"phases":608,"briefSummary":609,"conditions":610,"keywords":611,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":624},"100629808","phase-1-mrg006a-combination-therapy-for-advanced-hepatocellular-carcinoma-phase-iii-100629808","NCT07479485","MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I\u002FII)","An Open-Label, Multicenter, Phase I\u002FII Study Evaluating MRG006A in Combination With Immune Checkpoint Inhibitors and Targeted Therapy in Patients With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Able to understand and provide written informed consent, and comply with the requirements specified in the protocol.\n2. Life expectancy ≥ 3 months.\n3. Must provide tumor tissue specimens for GPC3 testing.\n4. Histologically\u002Fcytologically confirmed hepatocellular carcinoma (HCC), Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B not amenable to curative surgery and\u002For locoregional therapy.\n5. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and modified RECIST (mRECIST).\n6. No prior systemic antineoplastic therapy for unresectable HCC before first dose administration.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to first study drug administration.\n8. Adequate organ function as specified.\n9. Negative serum pregnancy test within 7 days prior to first dose (women of childbearing potential). Pregnant or lactating women are not eligible for this study.\n10. Women of childbearing potential and male patients must agree to use adequate contraception during MRG006A treatment and for 180 days after the last infusion.\n\nExclusion Criteria:\n\n1. Prior histologically\u002Fcytologically confirmed diagnosis of hepatocellular carcinoma with fibrolamellar, sarcomatoid, cholangiocarcinoma, or other components.\n2. History of hepatic failure or hepatic encephalopathy, or history of liver transplantation.\n3. Pleural effusion, ascites, or pelvic effusion, or clinically significant pericardial effusion.\n4. Acute or chronic active hepatitis B or hepatitis C infection.\n5. Central nervous system metastases.\n6. Prior locoregional therapy for hepatocellular carcinoma within 4 weeks before first dose administration.\n7. Receipt of live attenuated vaccines within 4 weeks before first dose or planned administration during the study period.\n8. Major surgical procedure within 4 weeks before first dose, or the presence of unhealed wounds, ulcers, or bone fractures.\n9. Uncontrolled or poorly controlled medical conditions.\n10. Toxicities from prior therapy that have not resolved to Grade 0 or 1 before first dose of study treatment.\n11. Severe cardiac insufficiency or cerebrovascular events within 6 months prior, or occurrence of pulmonary embolism, deep vein thrombosis, gastrointestinal perforation and\u002For fistula, or intestinal obstruction.\n12. Patients with double or multiple primary malignancies.\n13. Hypersensitivity to any component or excipient of the investigational product.\n14. Active or poorly controlled severe infection.\n15. Any severe and\u002For uncontrolled systemic disease that, in the opinion of the investigator and sponsor, renders the patient unsuitable for participation in this study.",{"count":607,"type":22},160,[25,100],"This is an open-label, multicenter, Phase I\u002FII clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MRG006A in combination with immune checkpoint inhibitors and targeted therapy in patients with advanced hepatocellular carcinoma (HCC).",[30],[612,613,614,615],"MRG006A","Pucotenlimab","Bevacizumab","TKI","2026-07-27",{"date":591,"type":54},{"date":619,"type":54},"2026-04-08",{"date":621,"type":22},"2029-04",{"name":623,"class":61},"Lepu Biopharma Co., Ltd.",8,{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":633,"enrollmentInfo":634,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":636,"conditions":637,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":161},"100639812","monterosa---italian-multicenter-observational-study-to-evaluate-time-to-clinical-hepatic-decompensation-quality-of-life-effectiveness-and-safety-of-tremelimumab-plus-durvalumab-in-patients-with-advanced-or-unresectable-hepatocellular-carcinoma-who-have-received-no-prior-systemic-treatment-100639812","NCT07607769","MONTEROSA - Italian Multicenter Observational Study to Evaluate Time to Clinical Hepatic Decompensation, Quality of Life, Effectiveness, and Safety of Tremelimumab Plus Durvalumab in Patients With Advanced or Unresectable Hepatocellular Carcinoma Who Have Received no Prior Systemic Treatment.","MONTEROSA Italian Multicenter Observational Study to Evaluate Time to Clinical Hepatic Decompensation, Quality of Life, Effectiveness, and Safety of Tremelimumab Plus Durvalumab in Patients With Advanced or Unresectable Hepatocellular Carcinoma Who Have Received no Prior Systemic Treatment. (Real World Observational Study of STRIDE Regimen for Advanced HCC)","MONTEROSA","Inclusion Criteria:\n\n* \\- Signed informed consent.\n* Age ≥ 18 years.\n* Histologically or radiologically confirmed diagnosis of advanced or unresectable HCC.\n* BCLC B or C HCC.\n* Child-Pugh A (score 5 or 6).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score 0 or 1.\n* Planned first-line treatment of advanced\u002FuHCC with STRIDE.\n\nExclusion Criteria:\n\n* \\- Any previous line of systemic therapy for HCC.\n* Any prior or concomitant immunotherapy.\n* Prior allogeneic organ or bone marrow transplant.\n* Documented active or previous GI bleeding within the previous 12 months.\n* Main trunk portal vein thrombosis.\n* Autoimmune disease requiring treatment with immunosuppressive medication.\n* Known hypersensitivity to the active substance or to any of the STRIDE excipients.\n* Pregnancy or breastfeeding","100 Years",{"count":635,"type":22},200,"Italian multicenter observational study to evaluate time to clinical hepatic decompensation, quality of life, effectiveness, and safety of tremelimumab plus durvalumab in patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic treatment.",[30],{"date":616,"type":54},{"date":640,"type":54},"2026-04-16",{"date":642,"type":22},"2028-10-31",{"name":220,"class":61},{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":4,"eligibilityCriteria":650,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":23,"phases":652,"briefSummary":654,"conditions":655,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":656,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":88},"100597515","phase-4-atezolizumab-and-bevacizumab-in-combination-with-y90-radioembolization-in-hcc-for-liver-transplant-100597515","NCT07059494","Atezolizumab and Bevacizumab in Combination With Y^90 Radioembolization in HCC for Liver Transplant","A Feasibility Clinical Trial of Atezolizumab and Bevacizumab in Combination With Y^90 Radioembolization for Patients With Hepatocellular Carcinoma (HCC) for Liver Transplantation","Inclusion Criteria:\n\n* Signed Informed Consent Form\n* Age ≥18 years at time of signing Informed Consent Form\n* Ability to comply with the study protocol\n* Newly diagnosed, biopsy-proven hepatocellular carcinoma (HCC) that is histologically or cytologically confirmed\n* Availability of a representative tumor specimen that is suitable for determination of PD-L1 status via central testing. A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 slides (15 slides preferred) slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study enrollment. If archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening. Availability of a representative tumor specimen for exploratory biomarker research. Newly diagnosed, biopsy-proven hepatocellular carcinoma (HCC) either outside of the Milan Criteria (MC), or within the MC, with high risk disease as defined by alpha-fetoprotein (AFP) ≥400 ng\u002FmL, and also fulfilling the criteria below.\n\n  1. Within MC with AFP ≥ 400 ng\u002Fml\n\n     1. single lesion (≤5cm) or 3 lesions (≤3cm)\n     2. Absence of vascular invasion or extra-hepatic disease based on cross-sectional imaging\n     3. Child-Pugh Score of A\u002FB7 (without ascites)\n  2. UNOS-DS Protocol\n\n     1. HCC exceeding UNOS T2 criteria but meeting one of the following:\n\n        * Single lesion ≤ 8 cm\n        * 2 or 3 lesions each ≤ 5 cm with the sum of the maximal tumor diameters ≤8 cm\n        * or 5 lesions each ≤ 3 cm with the sum of the maximal tumor diameters ≤ 8 cm\n     2. Absence of vascular invasion or extra-hepatic disease based on cross-sectional imaging\n     3. Child-Pugh Score of A\u002FB7 (without ascites)\n  3. Beyond UNOS-DS Liver Only Protocol a. HCC exceeding UNOS-DS criteria by any of the following:\n\n     * HCC tumor number\n     * HCC tumor size\n     * Total HCC tumor diameter b. Absence of vascular invasion or extra-hepatic disease based on cross-sectional imaging c. Child-Pugh Score of A\u002FB7 (without ascites)\n* Measurable disease, or non-measurable but evaluable disease, per RECIST v1.1 criteria\n* Must meet institutional standards for proteinuria (Urinalysis (pH, specific gravity, glucose, protein, ketones, and blood); dipstick permitted\n* Eligible for treatment with Y\\^90 and atezolizumab plus bevacizumab\n* ECOG performance status of 0-1\n* Life expectancy \\> 6 months\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:\n\n  * ANC 1.5 ≥ 10\\^9\u002FL (1500\u002FµL) without granulocyte colony-stimulating factor support, with the following exception:\n  * Participants with benign ethnic neutropenia (BEN): ANC \\\u003C 1.3 x 10\\^9\u002FL (1300\u002FμL) BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.\n\n    * Lymphocyte count ≥ 0.5 x 10\\^9\u002FL (500\u002FµL)\n    * Platelet count ≥ 100 x 10\\^9\u002FL (100,000\u002FµL) without transfusion\n    * Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL)\n  * Participants may be transfused to meet this criterion.\n\n    * AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 upper limit of normal (ULN)\n    * Serum bilirubin ≤ 1.5 x ULN with the following exception:\n  * Participants with known Gilbert disease: serum bilirubin ≤ 3 x ULN\n\n    * Serum creatinine ≤ 1.5 x ULN\n    * Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n    * For participants not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN\n    * For participants receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Absent or controlled HIV, HCV, and HBV o Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200\u002FμL, and have an undetectable viral load\n* Negative serum pregnancy test within 14 days prior to the initiation of study treatment for participants of childbearing potential.\n* Since adequate studies have not been performed in animals to determine whether Y\\^90 affects fertility in males or females has teratogenic potential or has other adverse effects on the fetus, this product should not be administered to pregnant or nursing women unless it is considered that the benefits to be gained outweigh the potential hazards. Ideally the use of this radioactive device in women of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.\n* Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods\n\nExclusion Criteria:\n\n* AFP ≥ 1000 ng\u002Fml\n* Pathologically mixed tumors, vascular invasion or extra-hepatic disease based on cross-sectional imaging\n* History of leptomeningeal disease\n* Uncontrolled tumor-related pain\n\n  o Participants requiring pain medication must be on a stable regimen at study entry.\n* Severe pulmonary disease, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) o Participants with indwelling catheters (e.g., PleurX®) are allowed\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, uncontrolled HIV, 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 (protocol lists a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:\n\n  * Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover \\\u003C 10 percent of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n    * There has been 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\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n\n  o History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 12 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis or standard HCC care, within 4-6 weeks prior to initiation of study treatment, or during the study\n* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to initiation of study treatment\n\n  o Placement of a vascular access device should be at least 2 days prior to initiation of study treatment\n* History of malignancy within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival (OS) rate \\> 90 percent), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, bladder cancer, carcinoma in situ, or Stage I uterine cancer\n* Severe active infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, active infection requiring IV antibiotics at the time of initiation of study treatment, or any active infection that could impact participant safety\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment\n\n  o Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell, solid organ, or multi-organ transplantation\n* 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 participant at high risk from treatment complications\n* Treatment with a live, attenuated vaccine 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\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* 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\n* 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 study treatment, with the following exceptions:\n\n  * Participants 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.\n  * Participants who received mineralocorticoids (e.g., 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.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Known allergy or hypersensitivity to any component of the study therapy\n* Prior locoregional or systemic therapy\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment.\n* Inadequately controlled hypertension (defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg)\n* History of hypertensive crisis or hypertensive encephalopathy\n* Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization\n* History of Grade ≥ 4 venous thromboembolism\n* History or evidence upon physical or neurological examination of central nervous system involvement\n* History of Grade ≥ 2 hemoptysis (defined as ≥ 2.5 mL of bright red blood per episode) within 1 month prior to screening\n* History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)\n* History of abdominal fistula, GI perforation, intra-abdominal abscess, or active GI bleeding within 6 months prior to randomization\n* Serious, non-healing wound, active ulcer, or untreated bone fracture\n* Current or recent (\\\u003C 10 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 aPTT is within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the participant 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.",{"count":383,"type":22},[653],"PHASE4","A single institution, single arm, two-cohort feasibility trial to evaluate the combination of locoregional Y\\^90 therapy with systemic atezolizumab and bevacizumab, in participants presenting with hepatocellular carcinoma (HCC) 1) within Milan Criteria (MC) with AFP ≥ 400 ng\u002Fml as a means of bridge therapy prior to transplant, 2) beyond the Milan Criteria (MC) (within USCF DS criteria and all comers), as a means of downstaging prior to liver transplantation.",[30],{"date":591,"type":54},{"date":658,"type":54},"2026-03-26",{"date":660,"type":22},"2028-08-01",{"name":662,"class":87},"Icahn School of Medicine at Mount Sinai",{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":4,"eligibilityCriteria":669,"healthyVolunteers":670,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":671,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":673,"conditions":674,"keywords":678,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":88},"100649344","analysis-of-breath-volatile-organic-compounds-using-mass-spectrometry-100649344","NCT07732686","Analysis of Breath Volatile Organic Compounds Using Mass Spectrometry","Breath Volatile Organic Compounds (VOC) Analysis Using Proton Transfer Reaction Mass Spectrometry (PTR-MS)","Inclusion Criteria:\n\n* Age ≥ 18 at the time of consent. Male and female patients to be tested.\n* Capable of understanding written and\u002For spoken English language.\n* Able to provide informed consent.\n* Cancer of any type.\n* Newly diagnosed cancer and untreated or established diagnosis of cancer. For established cancer patients, no active anti-cancer treatment for more than one month (reasons for no treatment are such as relapse, progression of cancer, refractory, or intolerance to treatment etc.)\n\nExclusion Criteria:\n\n* Under the age of 18.\n* Anticipated inability to complete breath sampling procedure.\n* Unable to provide informed consent.\n* Pregnant women\n* Active respiratory infection symptoms\n* Recent use of antibiotics\n* Difficulty in performing coached exhalation\n* Individuals who are unable to follow the instructions\n* Cancer patients who are on active treatment for cancer or have received cancer treatment within one month",true,{"count":672,"type":22},2000,"The purpose of this clinical trial is to evaluate whether volatile organic compound (VOC) signatures detected in the breath of patients with cancer can serve as a potential screening tool for the early detection of cancer.",[76,30,334,49,310,675,676,302,677],"Head and Neck Cancer","Colon Cancer","Other Cancer",[679,680,681],"VOC","PTR-MS","ML","2026-07-23",{"date":684,"type":54},"2026-07-29",{"date":686,"type":22},"2026-10",{"date":688,"type":22},"2029-10",{"name":690,"class":87},"University of Oklahoma",{"id":692,"slug":693,"hasResults":12,"nctId":694,"briefTitle":695,"officialTitle":695,"acronym":696,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":698,"targetDuration":4,"studyType":23,"phases":699,"briefSummary":700,"conditions":701,"keywords":702,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":704,"lastUpdatePostDateStruct":705,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":712},"100577270","identification-of-innovative-biomarkers-to-predict-outcomes-in-hepatocellular-carcinoma-treated-with-tremelimumab-and-durvalumab-100577270","NCT06796114","Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Durvalumab","PREDICT-HCC","Inclusion Criteria:\n\n1. Signed informed consent\n2. Histologically confirmed hepatocellular carcinoma\n3. Locally advanced, metastatic, or unresectable disease\n4. Patient who had not previously received systemic anti-cancer treatment and are eligible to STRIDE therapy according to investigator decision in routine care and who have no contraindications to STRIDE treatment according to approved product label.\n5. Measurable disease defined according to RECIST v1.1 guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)\n6. Age ≥ 18 years\n7. Patient affiliated to or beneficiary of French social security system\n8. Ability to comply with the study protocol, in the Investigator's judgment.\n\nExclusion Criteria:\n\n1. Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.\n2. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study\n3. Patient under guardianship, curatorship or under the protection of justice",{"count":361,"type":22},[73],"Several cancer immunotherapies that target the PD-L1\u002FPD-1 pathway (i.e., checkpoint inhibitors) show promising clinical activity in patients with HCC. In particular, atezolizumab selectively targets PD-L1 to prevent interaction with receptors PD-1 and B7-1, thus reversing T-cell suppression. Moreover, atezolizumab in combination with bevacizumab, a monoclonal antibody that targets VEGF and inhibits angiogenesis, is associated with an objective response rate of 27.3% (Cheng et al. 2021; Finn et al. 2020). This tumor response has led to FDA (Food and Drug Administration) and EMA (European Medicines Agency) approvals, in first-line treatment in unresectable HCC.\n\nCombinations studies evaluating anti-CTLA4 and anti-PD1\u002FPDL1 antibodies displayed greater benefits (Abou-Alfa et al. 2022). In the Phase 3 HIMALAYA study (NCT03298451) in uHCC, a single priming dose of tremelimumab (anti-CTLA-4) plus durvalumab (anti-PD-L1) in the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen significantly improved OS versus sorafenib; durvalumab monotherapy was noninferior to sorafenib for OS.\n\nIn the HIMALAYA study, STRIDE regimen induced long term survival (defined as the absence of progression above 36 months following inclusion) in 103 out of the 393 patients exposed to this strategy (26%).\n\nThe identification of biomarkers allowing the prediction of immunotherapy efficacy in HCC is still an unmet medical need.",[30],[703],"biomarker, immunotherapy","2026-07-22",{"date":682,"type":54},{"date":707,"type":54},"2025-06-25",{"date":709,"type":22},"2030-01-31",{"name":711,"class":87},"Centre Hospitalier Universitaire de Besancon",10]