[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepato-cellular-carcinoma-hcc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepato-cellular-carcinoma-hcc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,53,78,104,131,153,172,196,217,243,268,290,319,346,370,391,418,438],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100592225","outpatient-versus-inpatient-care-pathway-for-intra-arterial-treatment-of-primary-liver-cancer-choc-100592225",false,"NCT06990659","Outpatient Versus Inpatient Care Pathway for Intra-arterial Treatment of Primary Liver Cancer (CHOC)","CHOC - Implementation and Evaluation of an Ambulatory Care Pathway for Intra-arterial Treatment of Primary Liver Cancer: Study Protocol for a Multicentre Randomised Controlled Hybrid Type 1 Trial Implémentation et évaluation d'un Parcours de Soin Ambulatoire Pour Les Patients traités Par Voie Intra-artérielle d'un Cancer Primitif du Foie : Essai Multicentrique contrôlé randomisé","CHOC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* HCC or iCCA diagnosed according to the criteria of the European Association for the Study of the Liver (2024) or histologically proven.\n* Patient with HCC or iCCA eligible for intra-arterial treatment (transarterial chemoembolization \\[TACE\\] or transarterial radioembolization \\[TARE\\]), with no prior intra-arterial treatment of the same type as the one planned in the trial:\n\n  * no prior TACE for patients included for TACE;\n  * no prior TARE for patients included for TARE. Prior intra-arterial treatment of the other type is allowed (prior TACE before TARE, or prior TARE before TACE). Prior non-intra-arterial treatments are allowed.\n* If TACE is proposed at the multidisciplinary tumour board (RCP):\n\n  * Patient Child-Pugh \\\u003C B8\n  * Single or multiple HCC\n  * Absence of lobar or truncal portal obstruction\n  * Absence of bile duct dilatation\n* If treatment by TARE proposed in RCP:\n\n  * Absence of truncal portal tumor invasion\n  * Uni-lobar tumor invasion (except for centrohepatic iCCA)\n  * Total bilirubin \\\u003C 20 mg\u002Fl (or 35 µmol\u002FL)\n* Patient affiliated to or benefiting from a social security scheme\n* Patient having signed an informed consent form\n\nExclusion Criteria:\n\n* Technical contraindication or morphological elements of predictable technical difficulty\n* Planned combined same-day therapeutic strategies at the index procedure (e.g., TACE combined with percutaneous ablation) are not allowed; sequential (non-same-day) treatments are allowed.\n* Chronic renal insufficiency (Clairance \\\u003C 30 ml\u002Fmin)\n* Known allergy to a contrast agent or chemotherapy agent\n* inability to participate in ambulatory care (inability to understand and follow discharge instructions, lack of reliable telephone access, absence of a responsible accompanying adult for the first night after discharge, or inability to access urgent care in a timely manner if symptoms occur)\n* Patient previously included in the study\n* Patient who, for psychological, social, family or geographical reasons, could not be regularly monitored, patient who, for psychological, social, family or geographical reasons, could not be followed regularly\n* Concomitant disease or severe uncontrolled clinical situation\n* Severe uncontrolled infection\n* Pregnant, breast-feeding or parturient woman\n* Person deprived of liberty by judicial or administrative decision\n* Person under compulsory psychiatric care\n* Person under a legal protection measure\n* Person unable to give consent","ALL","18 Years",{"count":20,"type":21},206,"ESTIMATED","INTERVENTIONAL",[24],"NA","Randomized multicentre trial comparing two care organisations (ambulatory vs conventional inpatient) for patients undergoing transarterial chemoembolization (TACE) or radioembolization (TARE) for primary liver cancer (Hepato Cellular Carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA)). Patients are followed for 7 months to assess patient satisfaction, safety and clinical outcomes. A qualitative implementation study and a medico-economic evaluation (cost analysis and 5-years budget impact analysis) are embedded to assess acceptability, adoption, feasability, and sustainability and to inform scaling.",[27,28],"Hepato Cellular Carcinoma (HCC)","Intrahepatic Cholangiocarcinoma",[30,31,32,33,34,35,36,37,38,39],"ambulatory care","hospitalization","Hepato cellular carcinoma","Patient satisfaction","randomized trial","chemoembolization","radioembolization","Intrahepatic","Cholangiocarcinoma","Primary liver cancer","RECRUITING","2026-06-30",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":46,"type":44},"2025-12-18",{"date":48,"type":21},"2028-12-17",{"name":50,"class":51},"University Hospital, Angers","OTHER_GOV",19,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100641258","the-impact-of-anaesthesia-on-inflammation-and-netosis-in-hepatocellular-carcinoma-resection-100641258","NCT07657897","The Impact of Anaesthesia on Inflammation and NETosis in Hepatocellular Carcinoma Resection","Inclusion Criteria:\n\n* patients with a hepatocellular carcinoma suitable for RFA\n* tumor measuring up to 3 cm in diameter\n* ASA I, II, or III\n\nExclusion Criteria:\n\n* candidates for surgery\n* chronic immunosuppressive medication\n* contraindications to any of the study medications\n* patients with psychiatric disorders\n* autoimmune disorders\n* corticosteroid-dependent bronchial asthma\n* congenital or acquired coagulation disorders\n* HIV-positive patients\n* pregnant women\n* antiarrhythmic therapy","80 Years",{"count":61,"type":21},100,[24],"According to recent literature, liver disease causes approximately 2 million deaths annually; 1 million are attributed to the complications of cirrhosis, while the remaining deaths are caused by hepatocellular carcinoma (HCC). The latter currently ranks 16th among the leading causes of death worldwide.\n\nCurrent research focuses on investigating novel therapeutic modalities, optimizing surgical and anesthetic practices, and identifying biological biomarkers to predict disease progression and severity. In this study, we address radiofrequency ablation (RFA) with the goal of improving periprocedural prognosis, recurrence rates, and overall survival. Specifically, we will quantify the expression of NETosis, a relatively novel biomarker with potential therapeutic and prognostic value in HCC progression. NETosis is a regulated form of cell death through which granulocytes release decondensed chromatin and various proteases into the extracellular space, forming a web-like meshwork known as neutrophil extracellular traps (NETs). These structures are actively involved in hepatic tumorigenesis by promoting tumor growth and metastasis.\n\nRecent clinical data reveal that NETs play a key role in:\n\nLocal tumor progression\n\nThe incidence of hepatic metastasis\n\nDirect modulation of the immune response\n\nHepatic ischemia-reperfusion injury\n\nSeveral recent studies demonstrate that the in vivo blockade of NETosis reduces tumor recurrence, mitigates the pro-inflammatory state, and serves as a valuable prognostic indicator in advanced liver disease \\[2,3,4\\]. To suppress NETosis expression and ultimately lower recurrence rates, our protocol evaluates the intraprocedural administration of 1% lidocaine followed by a continuous postoperative intravenous lidocaine infusion.",[27,65,66],"Sedation and Analgesia","Ablation Techniques","2026-06-13",{"date":69,"type":44},"2026-06-18",{"date":71,"type":44},"2024-11-12",{"date":73,"type":21},"2026-11-12",{"name":75,"class":76},"Iuliu Hatieganu University of Medicine and Pharmacy","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":77},"100614169","phase-2-fecal-microbiota-transplantation-to-rescue-patients-with-unresectable-hcc-progressors-to-first-line-therapy-with-atezolizumab-and-bevacizumab-100614169","NCT07276100","Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hcc Progressors to First Line Therapy With AtezolizUmaB and Bevacizumab","Inclusion Criteria:\n\n1. Signed Informed Consent Form.\n2. Age ≥ 18 years.\n3. Tolerance to first-line treatment for HCC with atezolizumab plus bevacizumab, defined as absence of adverse events requiring permanent discontinuation of either drug.\n4. Ability to comply with all study procedures, in the investigator's judgment.\n5. Unresectable hepatocellular carcinoma with early disease progression on first-line atezolizumab + bevacizumab (within 4 months of treatment initiation).\n6. At least one untreated measurable lesion per RECIST 1.1.\n7. ECOG Performance Status 0-1.\n8. Child-Pugh class A.\n9. Adequate hematologic and end-organ function (laboratory values obtained within 7 days prior to enrollment), defined as follows:\n\n   1. ANC ≥ 1.5 × 10⁹\u002FL (1500\u002FµL), without G-CSF support.\n   2. Lymphocyte count ≥ 0.5 × 10⁹\u002FL (500\u002FµL).\n   3. Platelet count ≥ 60 × 10⁹\u002FL (60,000\u002FµL), without transfusion.\n   4. Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL); transfusion allowed if last transfusion ≥ 3 weeks prior.\n   5. AST, ALT, and ALP ≤ 5 × ULN.\n   6. Total bilirubin ≤ 3 × ULN.\n   7. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault).\n   8. Serum albumin ≥ 28 g\u002FL (2.8 g\u002FdL), without infusion supplementation in previous 2 months.\n   9. INR and aPTT ≤ 1.5 × ULN.\n10. Women of childbearing potential:\n\n    a. Agree to remain abstinent or use effective contraception (failure rate \\\u003C1%\u002Fyear) during treatment and for 5 months after last atezolizumab dose and 6 months after last bevacizumab dose.\n\n    b. Agree to refrain from donating eggs during this period.\n11. Men with female partners of childbearing potential:\n\n    1. Agree to remain abstinent or use a condom plus an additional contraceptive method (combined failure rate \\\u003C1%\u002Fyear) during treatment and for 6 months after last bevacizumab dose.\n    2. Agree to refrain from donating sperm during this period.\n\nExclusion Criteria:\n\n1\\. History of leptomeningeal disease or brain metastases.\n\n2\\. Active or prior autoimmune disease or immune deficiency (e.g., myasthenia gravis, myositis, autoimmune hepatitis, SLE, RA, IBD, antiphospholipid syndrome, Wegener, Sjögren, Guillain-Barré, MS), except:\n\n1. Autoimmune hypothyroidism on replacement therapy.\n2. Controlled Type 1 diabetes on insulin.\n3. Dermatologic-only autoimmune diseases (eczema, psoriasis, lichen simplex chronicus, vitiligo) if:\n\n   1\\. Rash \\\u003C10% BSA. 2. Well-controlled on low-potency topical steroids. 3. No exacerbations requiring systemic therapy within 12 months.\n\n   3\\. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on CT (radiation pneumonitis in field allowed).\n\n   4\\. Active tuberculosis.\n\n   5\\. Significant cardiovascular disease within 3 months (NYHA ≥ II, MI, CVA), unstable arrhythmia, or unstable angina.\n\n   6\\. Congenital long-QT syndrome or QTcF \\>500 ms at screening.\n\n   7\\. Active advanced malignancy other than HCC within 1 year.\n\n   8\\. Prior severe adverse reaction to atezolizumab or bevacizumab unmanageable with low-dose steroids or requiring discontinuation.\n\n   9\\. Uncorrectable electrolyte abnormalities (K, Ca, Mg).\n\n   10\\. Major surgery within 4 weeks or planned major surgery during study.\n\n   11\\. Severe infection within 4 weeks (including hospitalization, bacteremia, severe pneumonia).\n\n   12\\. Therapeutic oral\u002FIV antibiotics within 2 weeks (prophylactic antibiotics allowed). All within 30 days has to be recorded in eCRF.\n\n   13\\. Prior allogeneic stem cell or solid organ transplantation.\n\n   14\\. Any condition or laboratory abnormality posing excessive risk or interfering with study results.\n\n   15\\. Live attenuated vaccine within 4 weeks before treatment or planned during or 5 months after atezolizumab.\n\n   16\\. Severe allergic or anaphylactic reaction to humanized antibodies or fusion proteins.\n\n   17\\. Hypersensitivity to CHO cell products or components of atezolizumab or bevacizumab.\n\n   18\\. Pregnancy or breastfeeding; intent to become pregnant during treatment or post-treatment windows.\n\nPregnancy test required within 14 days pre-treatment.\n\n19\\. Fibrolamellar HCC, sarcomatoid HCC, or combined HCC-cholangiocarcinoma.\n\n20\\. Untreated or high-risk esophageal\u002Fgastric varices. EGD required; prophylactic treatment mandated.\n\n21\\. Variceal bleeding within 6 months.\n\n22\\. Clinically evident ascites.\n\n23\\. Episode of encephalopathy within 3 months.\n\n24\\. HBV\u002FHCV co-infection.\n\n25\\. Patients with prior HCV but negative HCV RNA are considered non-infected.\n\n26\\. Prior systemic therapy for advanced HCC other than first-line atezolizumab + bevacizumab.\n\n27\\. Systemic immunostimulatory agents (e.g., interferon, IL-2) within 4 weeks or 5 half-lives.\n\n28\\. Symptomatic, untreated, or actively progressing CNS metastases. Eligible only if all criteria are met: extracranial measurable disease, no hemorrhage history, lesions limited to cerebellum\u002Fsupratentorial region, no progression post-therapy, no recent RT\u002Fsurgery, no steroid requirement, stable anticonvulsants, new lesions treated before enrollment.\n\n29\\. Uncontrolled tumor-related pain; symptomatic lesions requiring RT must be treated first.\n\n30\\. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring ≥ monthly drainage.\n\nIndwelling catheters allowed.\n\n31\\. Uncontrolled or symptomatic hypercalcemia.\n\n32\\. Investigational therapy (other than atezolizumab + bevacizumab) within 28 days.\n\n33\\. Systemic immunosuppressive therapy within 2 weeks, except:\n\n1. Acute, low-dose, or one-time pulse steroids.\n2. Mineralocorticoids, inhaled steroids, low-dose steroids for adrenal insufficiency\u002Forthostatic hypotension.\n\n   34\\. Uncontrolled hypertension (SBP \\>150 mmHg and\u002For DBP \\>100 mmHg on multiple readings).\n\n   35\\. Prior hypertensive crisis or hypertensive encephalopathy.\n\n   36\\. Significant vascular disease within 6 months.\n\n   37\\. Hemoptysis \\>2.5 mL within 1 month.\n\n   38\\. Bleeding diathesis or significant coagulopathy.\n\n   39\\. Current or recent (within 10 days of first dose of study treatment) use of aspirin \\>325 mg\u002Fday or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.\n\n   40\\. Current or recent (within 10 days prior to study treatment start) use of full dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose. Prophylactic anticoagulation for the patency of venous access devices is allowed provided the activity of the agent results in an INR \\\u003C 1.5 x ULN and aPTT is within normal limits (ratio \\\u003C1.5) within 14 days prior to initiation of study treatment.\n\n   41\\. Core biopsy or minor surgery (except vascular access) within 3 days of first bevacizumab dose.\n\n   42\\. History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess within 6 months.\n\n   43\\. History of intestinal obstruction and\u002For clinical signs or symptoms of GI obstruction including subocclusive disease related to the underlying disease or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding prior to initiation of study treatment. Patients with signs\u002Fsymptoms of sub-\u002Focclusive syndrome\u002Fintestinal obstruction at time of initial diagnosis may be enrolled if they had received definitive (surgical) treatment for symptom resolution.\n\n   44\\. Abdominal free air not explained by procedure or surgery.\n\n   45\\. Serious non-healing wound, ulcer, or untreated bone fracture.\n\n   46\\. Metastatic disease involving major airways\u002Fblood vessels or large mediastinal masses (\\\u003C30 mm from carina).\n\n   Portal\u002Fhepatic vein invasion allowed.\n\n   47\\. Intra-abdominal inflammatory process (e.g., complicated PUD, diverticulitis, colitis) within 6 months.\n\n   48\\. Radiotherapy within 28 days (or abdominal\u002Fpelvic RT within 60 days), except palliative bone RT within 7 days.\n\n   49\\. Local liver therapy (RFA, ethanol, cryoablation, HIFU, TACE, TAE, SIRT) within 28 days or incomplete recovery.\n\n   50\\. Major surgery, open biopsy, abdominal surgery, abdominal intervention, or significant trauma within the specified windows or unresolved from such events.\n\n   51\\. Chronic daily NSAID use, except aspirin \\\u003C325 mg\u002Fday. Occasional use allowed.",{"count":85,"type":21},15,[87],"PHASE2","The purpose of this study is to evaluate whether fecal microbiota transplantation (FMT), when administered in combination with atezolizumab and bevacizumab, can improve treatment response in participants with hepatocellular carcinoma (HCC) whose disease has progressed during prior atezolizumab-bevacizumab therapy. The study will also assess the safety and feasibility of this treatment strategy.\n\nPrimary Objective:\n\nTo determine whether FMT can restore or enhance response to atezolizumab and bevacizumab following disease progression.\n\nParticipants will:\n\nReceive a fecal microbiota transplantation (FMT).\n\nResume treatment with atezolizumab and bevacizumab, administered every 3 weeks.",[27],[91,92,93,94],"hepato cellular carcinoma","atezolizumab","microbiota","fecal microbiota trasplant","2026-05-29",{"date":97,"type":44},"2026-06-01",{"date":99,"type":44},"2026-01-01",{"date":101,"type":21},"2029-01-01",{"name":103,"class":76},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":77},"100636044","phase-2-shield-sorafenib-hand-foot-syndrome-inhibition-with-pre-emptive-local-delivery-of-topical-indomethacin-100636044","NCT07560566","SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin","Inclusion Criteria:\n\n1. Female or male patients, 18 years of age or older, able to understand and give written informed consent.\n2. Hepatocellular carcinoma, diagnosed by clinical or pathological diagnosis.\n3. Patients with advanced HCC, defined as those with macrovascular invasion, extrahepatic spread, or who failed or are not feasible to locoregional therapy.\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n5. Child-Pugh score A-B7.\n6. Sorafenib is deemed as an appropriate treatment option for the patient at the discretion of the investigator.\n7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendices.\n8. Willing and able to comply with the requirements and restrictions in this protocol.\n\nExclusion Criteria:\n\n1. Exposure to multikinase inhibitors or capecitabine within 1 week before starting the study treatment.\n2. Unresolved HFS.\n3. Exposure to oral NSAID, topical NSAID, or topical steroid within 1 week before starting the study treatment.\n4. Known allergy to NSAID.\n5. Any concurrent systemic chemotherapy, immunotherapy, or biologic for cancer treatment.\n6. Recent gastrointestinal bleeding within 12 weeks.\n7. Female patients who are pregnant, breast-feeding, or male or female patients of reproductive potential who are not employing an effective method of birth control.\n8. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n9. Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study.",{"count":111,"type":21},39,[87],"SHIELD is a single-center, open-label, single-arm prospective study designed to evaluate whether pre-emptive topical indomethacin can reduce sorafenib-associated hand-foot syndrome (HFS) in patients with advanced hepatocellular carcinoma (HCC). Eligible adult patients with advanced HCC who are planned to initiate sorafenib will receive standard sorafenib treatment together with prophylactic 1% topical indomethacin gel applied to both hands twice daily for up to 12 weeks, or until development of HFS or discontinuation of sorafenib, whichever occurs first. The primary endpoint is the incidence of all-grade HFS during the first 12 weeks of sorafenib treatment. Secondary endpoints include grade 2 or higher HFS rate, grade 3 or higher HFS rate, mean sorafenib dose intensity during the first 12 weeks, adverse events of special interest, and duration of sorafenib treatment. The study will enroll 39 patients and compare outcomes with historical control data.",[27,115],"Hand Foot Skin Syndrome",[117,118,119,120,121],"hepatocellular carcinoma","Hand foot skin syndrome","Topical NSAID","Prophylaxis","Sorafenib","2026-04-27",{"date":124,"type":44},"2026-05-01",{"date":126,"type":44},"2025-12-09",{"date":128,"type":21},"2029-04-30",{"name":130,"class":76},"National Taiwan University Hospital",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":77},"100618160","phase-2-a-platform-trial-for-personalized-and-adaptive-therapies-in-hepatocellular-carcinoma-100618160","NCT07328009","A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma","The HCC-SIGHT: A Therapy Platform Trial for Hepatocellular Carcinoma Guided by Stratification Imaging and Genetic Horizon Testing","HCC-SIGHT","Inclusion Criteria:\n\n* Written informed consent obtained.\n* Age ≥ 18 years at time of study entry.\n* Locally advanced or metastatic and\u002For unresectable HCC with diagnosis confirmed by histology\u002F cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients.\n* Patients who have previously received first-line therapy with anti-PD-1\u002FPD-L1 combined with anti-VEGF antibodies, or anti-PD-1\u002FPD-L1 combined with TKI, or anti-PD-1\u002FPD-L1 combined with anti-CTLA-4 antibodies and experienced disease progression; or disease recurrence within 6 months after completion of neoadjuvant\u002Fadjuvant immunotherapy.\n* At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1.\n* Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).\n* Subjects with chronic HBV infection must have HBV DNA viral load \\\u003C 100 IU\u002FmL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy.\n* Life expectancy of at least 12 weeks.\n* Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500\u002FL, platelets ≥60 x103\u002FL; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g\u002FdL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* Patients on a liver transplantation list or with advanced liver disease.\n* History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment\n* Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.\n* Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.\n* Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.\n* Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to: a) history of interstitial lung disease b) Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection) c) known acute or chronic pancreatitis d) active tuberculosis e) any other active infection (viral, fungal or bacterial) requiring systemic therapy f) history of allogeneic tissue\u002Fsolid organ transplant g) diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment. h) Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma\u002Fatopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study. i) Live vaccine within 30 days prior to the first dose of treatment or during study treatment. j) History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS.\n* Medication that is known to interfere with any of the agents applied in the trial.\n* Any other efficacious cancer treatment except protocol specified treatment at study start.\n* Patient has received any other investigational product within 28 days of study entry.\n* Female subjects who are pregnant, breast-feeding or male\u002Ffemale patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). \\[Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner\\]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.",{"count":140,"type":21},350,[87],"This is a phase II, multi-arm, Bayesian adaptive platform trial designed to efficiently evaluate novel therapies for advanced hepatocellular carcinoma (HCC) after first-line treatment failure. The study aims to rapidly identify the most effective investigational regimens and discover predictive biomarker signatures (from tumor tissue, blood, and imaging) to guide personalized second-line therapy.",[27],"2026-04-18",{"date":146,"type":44},"2026-04-21",{"date":148,"type":44},"2026-01-19",{"date":150,"type":21},"2029-01-15",{"name":152,"class":76},"Fudan University",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":77},"100634215","phase-2-becotatug-vedotin-mrg003-in-previously-treated-advanced-hepatocellular-carcinoma-100634215","NCT07536789","Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma","Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma: A Single-arm, Multi-cohort, Phase 2 Trial","Inclusion Criteria:\n\n* Written informed consent obtained.\n* Age ≥ 18 years at time of study entry.\n* Locally advanced or metastatic and\u002For unresectable HCC with diagnosis confirmed by histology\u002F cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients.\n* Disease progression after ≥1 line of PD-1\u002FL1 inhibitors-based regimens.\n* Archival or fresh biopsied tumor tissue samples obtained for immunohistochemistry (IHC) testing to determine EGFR protein.\n* At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1.\n* Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).\n* Subjects with chronic HBV infection must have HBV DNA viral load \\\u003C 100 IU\u002FmL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy.\n* Life expectancy of at least 12 weeks.\n* Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500\u002FL, platelets ≥60 x103\u002FL; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g\u002FdL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* Patients on a liver transplantation list or with advanced liver disease.\n* History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment\n* Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.\n* Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.\n* Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.\n* Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to: a) history of interstitial lung disease b) Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection) c) known acute or chronic pancreatitis d) active tuberculosis e) any other active infection (viral, fungal or bacterial) requiring systemic therapy f) history of allogeneic tissue\u002Fsolid organ transplant g) diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment. h) Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma\u002Fatopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study. i) Live vaccine within 30 days prior to the first dose of treatment or during study treatment. j) History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS.\n* Medication that is known to interfere with any of the agents applied in the trial.\n* Any other efficacious cancer treatment except protocol specified treatment at study start.\n* Patient has received any other investigational product within 28 days of study entry.\n* Female subjects who are pregnant, breast-feeding or male\u002Ffemale patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). \\[Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner\\]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.\n* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.",{"count":161,"type":21},40,[87],"This study will evaluate the efficacy and safety of Becotatug vedotin, MRG003, in previously treated advanced hepatocellular carcinoma (HCC).",[27],"2026-04-16",{"date":146,"type":44},{"date":168,"type":44},"2026-04-17",{"date":170,"type":21},"2029-04-14",{"name":152,"class":76},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":4},"100630437","phase-2-tace-or-ablation-combined-with-sintilimab-and-ipilimumab-n01-as-neoadjuvant-therapy-for-resectable-hepatocellular-carcinoma-with-intermediate-high-recurrence-risk-100630437","NCT07487662","TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk","TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk: A Multicenter, Multigroup, Randomized, Phase Ⅱ Exploratory Clinical Trial","ACTION-001","Inclusion Criteria:\n\n* 1\\) Age: 18-75 years old; 2) Patients with hepatocellular carcinoma (HCC) classified as CNLC stage Ib-IIIa (excluding patients with Vp3 and Vp4), and deemed resectable by multidisciplinary team (MDT) discussion;\n\n  3\\) No prior tumor-related treatment received;\n\n  4\\) At least one measurable target lesion according to the RECIST 1.1 criteria;\n\n  5\\) ECOG PS score of 0-1;\n\n  6\\) Liver function classification: Child-Pugh Class A;\n\n  7\\) Estimated survival time ≥ 12 weeks;\n\n  8\\) Hematological, liver, and renal functions meet the following criteria:\n  1. Hemoglobin concentration ≥ 90 g\u002FL;\n  2. Neutrophil count ≥ 1.5 × 10⁹\u002FL;\n  3. Platelet count ≥ 75 × 10⁹\u002FL;\n  4. Total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal);\n  5. AST and ALT \\\u003C 5 × ULN; ALP \\\u003C 4 × ULN;\n  6. Creatinine ≤ 1.5 × ULN;\n  7. INR ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN;\n  8. Serum albumin concentration ≥ 30 g\u002FL;\n\n     9\\) Women of childbearing age must be excluded from pregnancy;\n\n     10\\) For patients with other concurrent malignant tumors, MDT discussion must confirm that the history and treatment history of other tumors will not interfere with the efficacy and safety evaluation of this study protocol;\n\n     11\\) Ability to understand and sign the informed consent form.\n\n     Exclusion Criteria:\n* 1\\) Prior history of HCC treatment; 2) Tumor rupture and bleeding, or suspected peritoneal metastasis;\n\n  3\\) History of other complex surgeries within 6 weeks;\n\n  4\\) Prior history of organ transplantation;\n\nCurrently receiving treatment in other clinical trials;\n\n5\\) Prior history of autoimmune diseases, inflammatory disorders (such as inflammatory bowel disease, etc.), diverticulitis, systemic lupus erythematosus, sarcoidosis syndrome, Wegener's syndrome (granulomatosis with polyangiitis, rheumatoid arthritis, etc.), except for the following cases: vitiligo or alopecia areata, hypothyroidism with stable condition after drug replacement therapy, chronic skin diseases that do not require systemic treatment, and celiac disease controllable by diet alone;\n\n6\\) Prior history of allergy to anti-PD1 drugs or anti-CTLA4 drugs, or allergy to chemical molecules similar to the above drugs, or prior severe allergic reaction to other monoclonal antibodies;\n\n7\\) Uncontrollable intermittent recurrent diseases, including but not limited to: persistent infections (including tuberculosis), hypertension uncontrollable by drugs (\\> 140\u002F90 mmHg), interstitial lung disease, severe chronic gastrointestinal diseases complicated with diarrhea, mental illness or social disorders that cannot comply with clinical research requirements, factors with high risk of side effects, and inability to sign the informed consent form;\n\n8\\) Patients with prior hepatic encephalopathy, refractory ascites, or esophagogastric varices with high bleeding risk; patients with upper gastrointestinal bleeding within 1 year before the first administration;\n\n9\\) Untreated active hepatitis B subjects (HBsAg positive and HBV-DNA exceeding 5000 copies\u002FmL (1000 IU\u002FmL) or higher than the lower limit of detection, whichever is higher); for subjects with hepatitis B, anti-hepatitis B virus treatment is required during the study treatment; active hepatitis C subjects (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);\n\n10\\) Patients with primary brain tumors (except meningiomas or other benign brain tumors), or any brain metastases, leptomeningeal carcinomatosis, epilepsy uncontrollable by conventional drugs, or new-onset stroke within 1 year;\n\n11\\) Primary immunodeficiency disease;\n\n12\\) Prior positive HIV test or acquired immunodeficiency syndrome (AIDS);\n\n13\\) Use of immunosuppressive drugs within 14 days before the start of study treatment. The following situations are exempt:\n\n1. Intranasal, inhaled, topically used steroids or local steroid injections;\n2. Systemic application of corticosteroids not exceeding the physiological dose (e.g., 10 mg\u002Fday prednisone or its equivalent);\n3. Steroid application for the treatment of allergic reactions;\n\n   14\\) Vaccination with live-attenuated vaccines within 30 days before the start of study treatment. Note: Live-attenuated vaccines should also be avoided during the study treatment and within 30 days after the end of treatment;\n\n   15\\) Receipt of systemic immunostimulant treatment within the prior 4 weeks;\n\n   16\\) Prior history of severe systemic diseases, including: myocardial infarction or unstable angina pectoris, hypertensive crisis or hypertensive encephalopathy, congestive heart failure of NYHA Class II or above, unstable symptomatic arrhythmia requiring drug intervention, severe vascular disease or symptomatic peripheral vascular disease, occurring within 12 months before the start of study treatment;\n\n   17\\) History of coagulative, hemorrhagic or thrombotic diseases within 12 months before the start of study treatment;\n\n   18\\) Severe, irreversible trauma, ulcers or fractures;\n\n   19\\) Pregnant or lactating women, or subjects planning to have children during the trial period;\n\n   20\\) Dependent on parenteral nutrition to maintain life;\n\n   21\\) Other acute or chronic diseases, mental and psychological diseases, etc., which are not suitable for participating in this study, as judged by the researcher.","75 Years",{"count":182,"type":21},105,[87],"Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide. The recurrence rate after curative resection for early-stage HCC remains extremely high, with 2-year and 5-year recurrence rates reaching 50% and 70%, respectively. Currently, no standard perioperative treatment is recommended in domestic and international guidelines.\n\nRecently, data from a phase III clinical study, investigating neoadjuvant and adjuvant therapy with camrelizumab plus apatinib in resectable HCC patients at intermediate-to-high risk of recurrence, demonstrated that the neoadjuvant and adjuvant therapy combining targeted therapy and immunotherapy could significantly reduce postoperative recurrence. The median recurrence-free survival (RFS) in the target-immunotherapy group was 42.1 months, which was remarkably longer than 19.4 months in the surgery-alone group.\n\nLocal therapies (TACE, ablation) can induce immunogenic cell death of tumors and remodel the tumor microenvironment, thereby exerting synergistic effects with immunotherapy. This strategy is expected to further improve recurrence-free survival in HCC patients after surgery.\n\nThis clinical trial aims to explore the efficacy and tolerability of the following regimens compared with surgery alone:\n\n1. TACE or ablation combined with anti-CTLA-4 and anti-PD-1 immunotherapy;\n2. TACE or ablation combined with anti-CTLA-4 + anti-PD-1 + lenvatinib;\n3. Dual immunotherapy with anti-CTLA-4 and anti-PD-1;\n4. Anti-CTLA-4 + anti-PD-1 + lenvatinib. Efficacy differences between groups will be compared using Bayesian statistical methods based on non-informative priors.",[27],"NOT_YET_RECRUITING","2026-03-23",{"date":189,"type":44},"2026-03-27",{"date":191,"type":21},"2026-03-18",{"date":193,"type":21},"2028-03-17",{"name":195,"class":76},"Sun Yat-sen University",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":212,"leadSponsor":214,"locationsCount":77},"100630958","phase-2-phase-2-study-of-wgi-0301-plus-nivolumab-in-patients-with-hcc-and-rcc-100630958","NCT07494435","Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With HCC and RCC","An Open-Label Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma or Advance Renal Cell Carcinoma","Inclusion Criteria:\n\n* 1\\) Age 18-75 (inclusive) on the day of singing informed consent, male or female.\n\n  2\\) Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol 3) Subjects in each disease cohorts will need to fulfill the following criteria:\n\n  • HCC Cohort:\n  1. Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria\n  2. 4\\. Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not suitable for any curative surgeries or locoregional therapy\n  3. Child-Pugh Liver Function Class A or Class B (score ≤ 7)\n  4. Documented first-line standard treatment failure (disease progression or intolerance)；\n\n     * nccRCC Cohort：Histologically or cytologically confirmed diagnosis of nccRCC，that is locally advanced or with distant metastasis, and have not received any prior systemic antitumor therapy. If disease progression occurs within 6 months after the last dose of adjuvant therapy, it is considered a failure of first-line treatment and thus does not meet the criteria.\n     * ccRCC Cohort：Histologically or cytologically confirmed ccRCC, with locally advanced unresectable disease or distant metastasis, and disease progression or intolerance after prior first-line therapy. Patients who have received adjuvant or neoadjuvant therapy may also be screened if they meet the above criteria.\n\n       4\\) Eligible for treatment with Nivolumab as determined by investigators according to the Package Insert and clinical judgment.\n\n       5\\) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 within 7 days prior to the first dose of study intervention 6) Life expectancy in the judgement of the Investigator \\> 12 weeks. 7) Patients must have at least one measurable lesion according to RECIST 1.1 as determined by the investigator, and that has not been the target of local or regional therapy such as radiotherapy; a new area of tumor progression within or adjacent to a previously treated lesion, if clearly measurable by a radiologist, is acceptable.\n\n       8\\) Any adverse events (AEs) related to prior anti-tumor therapy must have resolved to ≤ Grade 1 (CTCAE v6.0). However, patients may still be screened if the investigator determines that the toxicity is well-controlled and does not affect the patient's safety or compliance with the study drug, and this has been confirmed with the sponsor.\n\n       9\\) Collection of an archived tissue sample will be requested (where available) or agree to undergo tumor tissue biopsy for biomarker testing; however, a subject will not be precluded from participating in the study if tissue sample is not available for collection or is otherwise insufficient for analysis.\n\n       10\\) Patients must have adequate organ function as defined below:\n     * For patients with no liver metastasis or lesion: AST and ALT ≤2.0× ULN, and total bilirubin ≤1.5×ULN; For patients with liver metastasis or lesion: AST and ALT ≤3.0× ULN, and total bilirubin ≤2×ULN; For patients with Gilbert Syndrome: Total bilirubin ≤3×ULN\n     * Serum albumin≥30g\u002FL\n     * Creatinine Clearance (CrCL) ≥50 mL\u002Fmin (Cockcroft-Gault formula: Ccr=(140-Age)×body weight (Kg)\u002F72×Scr（mg\u002Fdl）{×0.85 for female subject}\n     * International Normalized Ratio (INR) ≤2.0 (except for patients on warfarin therapy)\n     * Hemeglobin≥90g\u002FL, ANC ≥1.5×10\\^9\u002FL, platelet count≥75×10\\^9\u002FL (no blood transfusion, blood products, cell growth factors, albumin or any other corrective therapeutic drugs within 14 days) 11) Participants with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection will be allowed if they meet the following criteria:\n     * HBV-HCC: Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen) or chronic HBV infection (as evidenced by detectable HBV surface antigen or HBV DNA). Subjects with chronic HBV infection must have HBV DNA \\\u003C 500 IU\u002F mL, and should be managed according to treatment guidelines. Those on antiviral therapy at screening should have been treated for \\>2 weeks before the first dose\n     * HCV-HCC: • HCV-HCC: Resolved HCV infection (as evidenced by detectable HCV RNA or antibody), or stable HCV infection (such as normal LFTs or being asymptomatic). Patients with positive HCV RNA requiring direct antiviral agent treatment, or those with HBV and HCV co-infection are excluded 12) Women of child-bearing potential (WOCBP) must have a negative serum pregnancy within 3 days prior to receiving the first dose of study medication and must use accepted highly effective methods of contraception from the time of signing the informed consent through 6 months after the last dose of study drug. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, or be surgically sterile, for the duration of study participation, and for 3 months after completion of study drug administration.\n\n     Exclusion Criteria:\n* 1\\) Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study 2) For the HCC Cohort, any of the following criteria：\n\n  * Locoregional therapy to liver within 4 weeks prior to the first dose, including but not limited to TACE, radiotherapy, radiofrequency ablation, microwave (except palliative radiotherapy for bone pain relief completed at least 2 weeks prior to the first dose).\n  * Fibrolamellar carcinoma, sarcomatoid hepatocellular carcinoma or mixed hepatocellular cholangiocarcinoma；\n  * 3\\. Complete occlusion of the major portal vein or vena cava due to HCC (The major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein) 3) Major surgery within 4 weeks prior to the first dose of study intervention. 4) Currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention (except for observational clinical trials) 5) Small molecule targeted therapy and traditional Chinese medicine with antitumor indications received within 2 weeks prior to the first dose, or chemotherapy, biological therapy, and other antitumor treatments received within 4 weeks prior to the first dose 6) Received systemic corticosteroid (prednisone \\>10mg\u002Fday or equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of study intervention. Inhale or local corticosteroid, or pre-medications for infusion-related reactions\u002F hypersensitivity is allowed.\n\n    7\\) Received live vaccines and live attenuated vaccines within 4 weeks prior to the first dose of study treatment, or expected to received live vaccinve or live attenuated vaccine while participating in the study 8) Previous identified allergy or hypersensitivity to components of WGI-0301 similar drugs or liposomal drugs, or Nivolumab or related excipients 9) Prior treatment with agents targeting the PI3K-AKT pathway 10) 13. Clinically significant cardiovascular disease including:\n  * Uncontrolled chronic hypertension defined as systolic \\> 150 mmHg or diastolic \\> 90 mmHg on more than one measurement despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings prior to enrollment is \\\u003C 150\u002F 90 mmHg)\n  * Hypotension as indicated by systolic blood pressure \\\u003C 90 mmHg or mean arterial pressure \\\u003C 65 mmHg on 2 consecutive measurements at the Screening Visit\n  * NYHA class III or IV Congestive heart failure, stroke, transient ischemic attack, pulmonary embolism, myocardial infarction, unstable angina pectoris, or left ventricular ejection fraction \\\u003C 50% within 6 months prior to the first dose.\n  * Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy)\n  * Bradycardia (known history of cardiovascular disease and either physical examination at rest or electrocardiogram indicating heart rate \\\u003C 50 bpm), or screening ECG indicating QTcF \\> 470 msec, 2 retests are required for the first abnormal QTcF , and the mean value should be taken from the 3 readings. Or there is severe arrhythmia requiring further treatment, including but not limited to ventricular fibrillation, atrial fibrillation, sustained ventricular tachycardia, second-degree or third-degree atrioventricular block, torsades de pointes, etc.\n\n    11\\) Clinically significant bleeding risks including:\n  * Known hereditary or acquired bleeding or thrombotic tendencies (e.g., hereditary hemorrhagic telangiectasia or von Willebrand disease)\n  * History of bleeding symptoms due to esophageal or gastric varices within 6 months prior to the first dose\n  * Received thrombolytic agents within 10 days prior to the first dose, or currently receiving anticoagulant therapy (e.g. anticoagulant, antiplatelet) and subject 's INR and APTT are not within expected therapeutic range of anticoagulant (except sodium heparin for maintenance of central venous catheter patency) 12) Known HIV or AIDS related illness, or history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant 13) Patients with endocrine disorders that cannot be effectively controlled by hormone replacement therapy 14) Presence of active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, including but not limited to: systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, etc. However, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency managed with hormone replacement therapy only; skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia); or conditions not expected to recur in the absence of external triggers are allowed.\n\n    15\\) History of gastrointestinal perforation, gastrointestinal or non-gastrointestinal fistula, or abdominal abscess within 6 months prior to the first dose 16) Skin ulcers or severe, non-healing, or dehisced wounds within 3 months prior to the first dose 17) Known active or uncontrolled infection that may interfere with the study (e.g., active infection requiring intravenous antibiotic therapy or unexplained fever \\>38.5°C) 18) History of interstitial lung disease or prior non-infectious pneumonitis requiring corticosteroid treatment, or imaging findings suggestive of active pneumonia 19) History of other malignancies prior to or at study entry (except for adequately treated carcinoma in situ of the cervix, basal cell and squamous cell skin cancer, or other malignancies that have undergone curative treatment with no evidence of disease for at least 3 years).\n\n    20\\) Pleural effusion, ascites, or pericardial effusion that are clinically symptomatic or requiring repeated drainage (as judged by the investigator) 21) Known symptomatic or untreated brain metastases, leptomeningeal metastases, or other central nervous system metastases (except for asymptomatic cases not requiring treatment).\n\n    22\\) History of drug abuse or addiction 23) Subject has any other conditions or reason that, in the opinion of the Investigator, interferes with the ability of the subject to participate in the trial, places the subject at undue risk or complicates the interpretation of data",{"count":204,"type":21},230,[87],"This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with nivolumab, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer or advanced kidney cancer.",[27,208],"Renal Cell Cancer","2026-03-19",{"date":189,"type":44},{"date":97,"type":21},{"date":213,"type":21},"2028-09-01",{"name":215,"class":216},"Zhejiang Haichang Biotech Co., Ltd.","INDUSTRY",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":77},"100628441","phase-3-effects-of-neoadjuvant-immunotherapy-on-anti-tumour-immunity-in-hepatocellular-carcinoma-patients-undergoing-liver-resection-100628441","NCT07461675","Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients Undergoing Liver Resection","Inclusion Criteria:\n\n* All adult patients undergoing liver resection for HCC at the Geneva University Hospitals (HUG), with prior informed and signed consent.\n* Patients of childbearing age must be willing to use a contraception at the day of inclusion and for at least 5 months after the last infusion.\n* Negative pregnancy test at inclusion\n* Patients will require to be eligible for surgical resection according to the BCLC guidelines (very early to early stage with preserved liver function and good patient condition) (4).\n* The control group will include data from the patients in our ongoing research project (study protocol 2023-02372), undergoing liver resection without prior ICI therapy (n = 30).\n\nExclusion Criteria:\n\n* Patients who do not ultimately undergo liver resection due to unforeseen reasons (this happens rarely, such as in the presence of unexpected HCC progression discovered during surgery).\n* Patients with an ongoing pregnancy (an unlikely event, as non-surgical HCC treatments would be prioritized in such cases).\n* Patients unable to follow procedures due to language barriers, insufficient comprehension of project language, or unable to give consent.\n* Patients \\\u003C18 years.\n* Patients with medical history of allergy or severe AEs to ICI therapy\n* Pregnant and\u002For breastfeeding women. Lactating women should stop lactation or will be excluded from the study as breastfeeding under atezolizumab is not recommended. Furthermore, breastfeeding is not recommended for at least 5 months after the last dose.\n* Immunosuppressed patients and patients with haematological disorder leading to a deficient immunity\n* Patients with hepatic and\u002For cardiovascular deficiencies that contra-indicate surgery. Compensated cirrhotic patients are expected and will be included in the study as no dosage modification of the atezolizumab is required for these patients.\n* Patients who received a live or attenuated vaccine in the last 28 days before inclusion in the study.\n* Patients with untreated Hepatitis B and\u002For C or HIV. HIV patients under treatment with normal CD4 counts can be included. Hepatitis B and\u002For C patients under antiviral therapies can be included.\n* Patients with history of inflammatory pneumopathy, active brain metastasis and patients treated with a systemic immunotherapy in the last 6 months.\n* Patients under steroid treatment during the inclusion will be excluded.",{"count":224,"type":21},30,[226],"PHASE3","Our study aims to evaluate the benefit of the administration of immunotherapy (atezolizumab), in patients with hepatocellular carcinoma (HCC), prior surgical resection of the tumor.\n\nHCC is the most prevalent primary liver cancer, responsible for nearly 800,000 deaths annually, making it the third leading cause of cancer-related mortality worldwide. Ablation by radiologic micro-waves or surgical resection represent at the moment the only curative therapies for early stages of the disease. Despite these curative options, HCC recurrence is frequent.\n\nRecently, immunotherapy has demonstrated good results on patient overall survival for advanced stages of HCC in comparison to sorafenib. Because of the beneficial effect of immunotherapy on HCC, several groups have attempt to use it as adjuvant therapy in order to reduce the recurrence rate. However the results are at the moment controversial. One can hypothetize that postoperative inflammation and liver regeneration can negatively impact the effect of the immunotherapy. Therefore, the administration of the treatmeent before surgical resection could overcome this issue.",[27,229],"Immunotherapy",[231,232,92,233],"Neoadjuvant treatment","Hepatocellular carcinoma","hepatectomy","2026-03-04",{"date":236,"type":44},"2026-03-10",{"date":238,"type":21},"2026-03-25",{"date":240,"type":21},"2029-12-31",{"name":242,"class":76},"University of Geneva, Switzerland",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":267},"100616231","phase-2-transarterial-chemoembolization-tace-plus-abcb1-inhibition-versus-tace-alone-in-patients-with-hepatocellular-carcinoma-100616231","NCT07302919","Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma","Randomized, Double-Blind, Parallel, Controlled, Multicenter Study of Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma: IMPACT-TACE","IMPACT-TACE","Inclusion Criteria:\n\n* Informed consent as documented by signature,\n* Age ≥18 years,\n* Diagnosis of HCC by biopsy or by established imaging criteria using CT or MRI,\n* At least one target lesion without prior treatment,\n* Diameter of the target lesion ≥3 cm and ≤8 cm,\n* Preserved liver function (no jaundice, no ascites, no overt hepatic encephalopathy).\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods for at least 3 months after the TACE treatment.\n\nExclusion Criteria:\n\n* Any prior systemic therapy for advanced HCC,\n* Diffuse tumor lesions, extrahepatic metastases, or vascular invasion,\n* Hepatic encephalopathy,\n* Uncontrolled ascites or pleural effusion,\n* Jaundice,\n* Severe hypotension or hemodynamic shock or need of vasoactive medications,\n* Decompensated heart failure New York Heart Association (NYHA) class IV,\n* eGFR \\\u003C 15 mL\u002Fmin\u002F1.73 m2 per MDRD (Modification of Diet in Renal Disease) formula,\n* Myocardial infarction within the last 6 months,\n* Life expectancy \\\u003C12 weeks,\n* Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to calcium antagonists,\n* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 3 months after the TACE treatment.",{"count":252,"type":21},152,[87,226],"IMPACT-TACE is an investigator-initiated, prospective, multicenter, randomized, double-blinded, interventional trial to test the hypothesis that the simultaneous application of doxorubicin with the ABCB1 inhibitor nicardipine would significantly improve the success rate of TACE treatment.",[27],[257],"Transarterial Chemoembolization (TACE)","2026-02-26",{"date":260,"type":44},"2026-03-02",{"date":262,"type":44},"2026-02-16",{"date":264,"type":21},"2028-06",{"name":266,"class":76},"University Hospital, Basel, Switzerland",3,{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":77},"100613531","phase-3-camrelizumab-and-apatinib-with-or-without-folfox-chemotherapy-for-advanced-hcc-100613531","NCT07267806","Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC","Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy as First-Line Treatment for Advanced Hepatocellular Carcinoma (HCC): A Randomized, Controlled, Open-Label, Multicenter Phase III.","Inclusion Criteria:\n\n1. Patients volunteered to participate in this study and signed informed consent;\n2. ≥18 years old, male and female;\n3. Before treatment, it was confirmed by histopathology or cytology, or clinically diagnosed as hepatomegaly.Patients with Hepatocellular Carcinoma, HCC);\n4. BCLC stage B or C hepatocellular carcinoma, which is not suitable for curative surgical or local therapies, or has progressed after such treatments.\n5. Local therapy (including but not limited to surgery, radiation therapy, transarterial chemoembolization \\[TACE\\], hepatic arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) must have been completed at least 4 weeks prior to the baseline radiographic scan (with the exception of palliative radiotherapy, for which a 2-week interval is sufficient).\"\n6. Has not received any systemic treatment for HCC.\n7. According to RECIST 1.1 standard, patients have at least one measurable lesion (CT\u002FMRI scan long diameter ≥10mm or CT\u002FMRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);\n8. Child-pugh liver function grading: Grade A or Grade Better B (≤7 points)\n9. ECOG PS score 0-2;\n10. Expected survival ≥ 12 weeks;\n11. Major organ functions are basically normal and meet the following requirements (within 7 days before starting the study treatment):\n\n    1. Complete blood count: absolute neutrophil count ≥ 1.5\\*10\\^9\u002FL, platelets (PLT) ≥ 75\\*10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL;\n    2. Blood biochemistry: albumin ≥ 25 g\u002FL; total bilirubin ≤ 3.0 × upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 5 × ULN; creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CrCl) \\> 50 mL\u002Fmin.\n    3. International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) no more than 6 seconds above the normal control range;\n    4. Urine protein \\\u003C2 (if urine protein ≥2, a 24-hour urine protein quantification can be performed; 24-hour urine protein \\\u003C1.0 g is allowed for inclusion).\n12. Patients with active hepatitis B virus (HBV) infection must receive anti-HBV therapy prior to initiating study treatment and be willing to continue antiviral therapy throughout the study; hepatitis C virus (HCV) RNA-positive patients must receive antiviral therapy according to local standard treatment guidelines with liver function not exceeding CTCAE grade 1 elevation.\n13. Women of childbearing potential should have a negative serum or urine pregnancy test within 7 days prior to study enrollment, must not be breastfeeding, and must agree to use contraception during the study and for 6 months after the study; men must agree to use contraception during the study and for 6 months after the study.\n\n    \\-\n\nExclusion Criteria:\n\n1. Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibrolamellar carcinoma; having other active malignancies within the past 5 years or simultaneously, excluding HCC. Successfully treated localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included.\n2. Patients who are preparing for or have previously undergone organ or allogeneic hematopoietic stem cell transplantation;\n3. Patients with clinical symptoms of moderate to severe ascites that require therapeutic puncture or drainage; uncontrolled pleural effusion or pericardial effusion of moderate amount or more;\n4. Patients with a history of gastrointestinal bleeding within 6 months before the start of the study treatment or a clear tendency for gastrointestinal bleeding, such as: high-risk or severe esophageal and gastric varices, localized active gastrointestinal ulcer lesions, or persistent positive fecal occult blood;\n5. Patients who have had abdominal fistulas, gastrointestinal perforation, or intra-abdominal abscesses within 6 months before the start of the study treatment;\n6. Patients with known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombophilia.\n7. Currently using or having recently used (within 10 days before the start of the study treatment) aspirin \\[\\>325 mg\u002Fday (maximum antiplatelet dose)\\] or dipyridamole, ticlopidine, clopidogrel, and cilostazol;\n8. Occurrence of thrombotic or embolic events within 6 months before the start of the study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary .embolism).\n9. Uncontrolled cardiac clinical symptoms or conditions, such as:\n\n   1. Heart failure of NYHA class II or above;\n   2. Unstable angina;\n   3. Myocardial infarction occurring within the past year;\n   4. Clinically significant supraventricular or ventricular arrhythmias requiring medical intervention;\n   5. Patients with hypertension whose condition is poorly controlled by medication and who are assessed by a doctor to be at high risk when using apatinib;\n10. Suffering from hypertension that cannot be well controlled with antihypertensive medication (systolic ≥140 mmHg or diastolic ≥90 mmHg); history of hypertensive crises or hypertensive encephalopathy;\n11. Major vascular disease occurring within 6 months prior to the start of study treatment (e.g., an aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis);\n12. Severe, non-healing, or dehisced wounds, as well as active ulcers or untreated fractures;\n13. Undergoing major surgery (except for diagnosis) within 4 weeks before the start of study treatment or anticipated need for major surgery during the study period;\n14. Inability to swallow pills, malabsorption syndrome, or any condition affecting gastrointestinal absorption;\n15. History of intestinal obstruction and\u002For clinical signs or symptoms of gastrointestinal obstruction within 6 months before starting study treatment;\n16. Evidence of intra-abdominal gas that cannot be explained by puncture or recent surgery;\n17. Past or present central nervous system metastases; 18. History of hepatic encephalopathy.\n18. Currently accompanied by interstitial pneumonia or interstitial lung disease, or with a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or other conditions that may interfere with the assessment and management of immune-related lung toxicity, such as pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or severely impaired lung function; active tuberculosis;\n19. Currently accompanied by interstitial pneumonia or interstitial lung disease, or with a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or other conditions that may interfere with the assessment and management of immune-related lung toxicity, such as pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or severely impaired lung function; active tuberculosis;\n20. Subjects with active autoimmune diseases or a history of autoimmune diseases that may relapse (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[subjects whose condition can be controlled solely with hormone replacement therapy may be included\\]); subjects with skin diseases that do not require systemic treatment such as vitiligo, psoriasis, or alopecia, subjects with type 1 diabetes controlled with insulin therapy, or subjects whose childhood asthma has fully resolved and require no intervention as adults may be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included.\n21. Use of immunosuppressants or systemic steroid therapy within 14 days prior to the start of study treatment to achieve immunosuppression (dose \\>10 mg\u002Fday of prednisone or other equivalent steroids);\n22. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications; oral or intravenous therapeutic antibiotics within 2 weeks prior to the start of study treatment (patients receiving prophylactic antibiotics are eligible for the study, such as for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease);\n23. Congenital or acquired immunodeficiency (e.g., HIV infection);\n24. Coinfection with hepatitis B and hepatitis C;\n25. Prior treatment with other anti-PD-1 antibodies or other PD-1\u002FPD-L1 targeted immunotherapies, or prior treatment with apatinib;\n26. Vaccination with live attenuated vaccines within 28 days prior to the start of study treatment, or anticipated need for such vaccines during camrelizumab treatment or within 60 days after the last dose of camrelizumab;\n27. Treatment with other investigational drugs within 28 days prior to the start of study treatment.\n28. According to the researcher's judgment, the patient has other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe illnesses (including psychiatric disorders) requiring combined treatment, significant abnormalities in laboratory tests, or family or social factors that could affect the patient's safety.",{"count":276,"type":21},326,[226],"This is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC).",[27,280],"Chemotherapy Effect","2025-12-08",{"date":283,"type":44},"2025-12-16",{"date":285,"type":44},"2025-10-31",{"date":287,"type":21},"2032-10",{"name":289,"class":76},"Linhui Peng",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":298,"targetDuration":4,"studyType":300,"phases":4,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":77},"100604345","hepatocellular-carcinoma-identification-using-delta-hld-100604345","NCT07148310","Hepatocellular Carcinoma Identification Using Delta-HLD","Proof-of-Concept Case-Control Study for Hepatocellular Carcinoma Identification Using Delta-HLD Technology (HIDE)","HIDE","Inclusion Criteria:\n\n* Histologically confirmed HCC (cases) or clinically confirmed liver cirrhosis without HCC (controls)\n* Willing and able to provide informed consent\n* Available paired plasma and liver tissue sample\n\nExclusion Criteria:\n\n* Other active cancers\n* Prior liver transplantation\n* Known hereditary cancer syndromes\n* Recent chemotherapy or antiviral treatment (\\\u003C3 months)",{"count":299,"type":21},200,"OBSERVATIONAL","HIDE (Hepatocellular Carcinoma Identification via Delta-HLD) is a proof-of-concept case-control study designed to evaluate the performance of delta-HLD, Epiliquid's proprietary liquid biopsy technology, in detecting hepatocellular carcinoma (HCC). The study includes both plasma and tissue samples to assess biomarker concordance and evaluate diagnostic sensitivity and specificity using tumor-specific methylation markers detected by PCR.",[27],[232,304,305,306,307,308,309],"Epigenetics","Liquid Biopsy","cfDNA","Biomarker","Methylation","PCR","2025-09-08",{"date":312,"type":44},"2025-09-09",{"date":314,"type":44},"2023-05-18",{"date":316,"type":21},"2026-12",{"name":318,"class":216},"Epiliquid Holding, Inc",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":326,"targetDuration":328,"studyType":300,"phases":4,"briefSummary":329,"conditions":330,"keywords":334,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":77},"100603876","effect-and-mechanism-of-alpps-operation-on-liver-regeneration-100603876","NCT07142213","Effect and Mechanism of ALPPS Operation on Liver Regeneration","Effect and Mechanism of Combined Hepatectomy and Portal Vein Ligation Staged Hepatectomy (ALPPS) on Liver Regeneration in Patients With Hepatobiliary Malignancy","Inclusion Criteria:\n\n1. Age: Patients aged 18 to 75 years\n2. Diagnosis established: A diagnosis of hepatobiliary malignancy (including hepatocellular carcinoma and cholangiocarcinoma) was confirmed and evaluated as suitable for ALPPS surgery\n3. Liver function status: preoperative Child-Pugh score A or B, MELD score ≤15, with sufficient liver function reserve for operation\n4. Tumor characteristics: bilobal or complex tumors of the liver with large tumor areas requiring ALPPS to ensure adequate residual liver volume (FLR\u002FTLV\\\u003C30% or FLR\u002FBW\\\u003C0.5)\n5. Preoperative assessment: Imaging showed that future liver residual (FLR) was insufficient to support standard hepatectomy, and liver volume must be increased by ALPPS\n6. FLR enlargement: Postoperative assessment of FLR enlargement as expected (at least 30% enlargement or FLR\u002FBW above 0.5) for a second procedure\n7. No distant metastases: No unresectable extrahepatic metastases, except for resectable lung metastases\n\nExclusion Criteria:\n\n1. Preoperative FLR insufficiency: Residual liver volume (FLR) did not increase sufficiently after the first step (\\\u003C30% increase or FLR\u002FBW \\\u003C0.5) to be suitable for the second step\n2. Extrahepatic metastasis: unresectable distant metastasis, such as extensive metastasis of bone, lung, etc\n3. Severe liver disease: very poor liver function before surgery, Child-Pugh grade C or severe liver sclerosis during surgery (e.g. Metavir≥F3 or 30% or more hepatic steatosis)\n4. Major comorbidities: Major illnesses such as severe cardiovascular disease, kidney failure, or respiratory failure that do not tolerate major surgery\n5. Postoperative complications: Serious postoperative complications (such as liver failure, infection, etc.) after the first step are not suitable for the second step\n6. Evaluation of adverse surgery: After the first procedure, FLR blood supply or function is abnormal, affecting liver regeneration\n7. Pregnancy and lactation: pregnant or lactating women",{"count":327,"type":21},50,"1 Year","Hepatobiliary malignancies-principally hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA)-are highly aggressive and often diagnosed at advanced stages. Curative-intent liver resection remains the standard for resectable disease; however, postoperative outcomes depend on an adequate functional future liver remnant (FLR). Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) induces rapid FLR hypertrophy and has expanded resection eligibility compared with conventional two-stage hepatectomy by shortening the interval to definitive resection.\n\nKey uncertainties persist regarding the quality of ALPPS-induced regeneration and its relationship to long-term oncologic outcomes, including recurrence and metastasis. This observational study enrolls patients deemed suitable for ALPPS at Peking Union Medical College Hospital. Perioperative care follows institutional standards; no therapeutic procedures are altered for research purposes. The investigators will collect clinically available liver tissue and relevant medical data obtained during standard surgical care to characterize cellular and molecular programs of regeneration across the ALPPS stages.\n\nHigh-throughput profiling-including single-cell and spatial transcriptomics-will be used to define cell-type composition, transcriptional states, and signaling pathways associated with regeneration. The primary objective is to describe cellular and gene-expression changes in regenerating liver induced by ALPPS. Secondary objectives include exploring associations between regenerative quality and short- and long-term clinical outcomes. Findings are expected to inform potential therapeutic targets and strategies to enhance safe regeneration and improve postoperative prognosis.",[27,331,332,333],"Hepatobiliary Cancers","Liver Cancer","Liver Regeneration",[335,336,233],"liver regeneration","ALPPS","2025-08-23",{"date":339,"type":44},"2025-08-26",{"date":341,"type":44},"2020-01-01",{"date":343,"type":21},"2028-12-31",{"name":345,"class":76},"Haitao Zhao, MD",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":300,"phases":4,"briefSummary":355,"conditions":356,"keywords":357,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":77},"100589934","fibroscan-evaluating-immunotherapy-response-in-hepatocellular-carcinoma-100589934","NCT06960863","Fibroscan Evaluating Immunotherapy Response in Hepatocellular Carcinoma","Transient Elastography (Fibroscan) for Evaluation of Immunotherapy Response in Hepatocellular Carcinoma.","Inclusion Criteria:\n\n* Patients with confirmed advanced HCC (Diagnosed by two imaging modalities or liver biopsy) eligible for immunotherapy.\n* Patients with preserved liver function (compensated Child-Pugh A if there is underlying cirrhosis).\n* Patients with performance status ≤2 at staging work-up.\n* absence of high-risk stigmata for bleeding on upper endoscopy, e.g. properly treated oesophageal varices and no history of variceal bleeding, in order to minimise bleeding risk.\n\nExclusion Criteria:\n\n* Prior locoregional therapy or liver transplantation.\n* Child-Pugh class C patients.\n* Patients with performance status \\>2 at staging work-up.\n* Vascular disorders, arterial hypertension, and risk of variceal bleeding.\n* Severe autoimmune disorders.\n* Patients who lost follow-up.\n* Pregnant or breastfeeding women.\n* Unwilling to participate in our study.",{"count":354,"type":21},80,"The goal of this prospective cohort study is to evaluate the role of transient elastography (Fibroscan) in predicting the response of immunotherapy in advanced Hepatocellular carcinoma (HCC) patients.\n\nResearchers will predict the response to 6 months of HCC immunotherapy regarding improvement of the degree of liver fibrosis, development of liver decompensation, complications, survival, and mortality.\n\nParticipants will undergo history-taking, clinical examination, laboratory investigations, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, Triphasic CT abdomen with contrast or MRI (for evaluation of tumor site, size and number), and Fibroscan examination at baseline and follow-up after 6 months.",[27],[358,359,360,117],"fibroscan","immunotherapy","liver stiffness","2025-04-29",{"date":363,"type":44},"2025-05-07",{"date":365,"type":44},"2025-01-26",{"date":367,"type":21},"2026-01-31",{"name":369,"class":76},"Tanta University",{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":300,"phases":4,"briefSummary":379,"conditions":380,"keywords":382,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":77},"100589941","pivka-ii-for-predicting-portal-vein-thrombosis-in-hepatocellular-carcinoma-100589941","NCT06960954","PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma","Prothrombin Induced by Vitamin K Absence II (PIVKA-II) Serum Level as a Predictor for Portal Vein Tumor Thrombosis in Hepatocellular Carcinoma Patients.","Inclusion Criteria:\n\n* Male or female patients older than 18 years.\n* Patients with confirmed HCC with or without PVTT (Diagnosed by two imaging modalities or one imaging modality with elevated serum alpha fetoprotein or liver biopsy).\n\nExclusion Criteria:\n\n* Prior locoregional therapy or liver transplantation.\n* Patients on vitamin K, vitamin K antagonists or antibiotics.\n* Patients with cholestasis.\n* Patients with renal insufficiency.\n* Patients with other malignancies.\n* Unwilling to participate in our study.",{"count":378,"type":21},116,"The goal of this cross-sectional observational study is to evaluate the relation between Prothrombin induced by vitamin K absence II (PIVKA-II) and the presence of portal vein tumor thrombosis (PVTT) in hepatocellular carcinoma (HCC) patients.\n\nResearchers will compare PIVKA-II serum levels in HCC patients with PVTT and without PVTT.\n\nParticipants will undergo history-taking, clinical examination, laboratory investigations, PIVKA-II serum level, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, and Triphasic CT abdomen with contrast or MRI to evaluate tumor site, size, number, and presence of PVTT (a filling defect in the portal vein or its branch to distinguish PVTT or thrombus).",[27,381],"Portal Vein Tumour Thrombosis",[383,384,232],"PIVKA-II","Portal vein tumor thrombosis",{"date":363,"type":44},{"date":387,"type":44},"2025-01-15",{"date":389,"type":21},"2025-12-31",{"name":369,"class":76},{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":300,"phases":4,"briefSummary":399,"conditions":400,"keywords":403,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":4},"100584835","retrospective-clinical-validation-of-hepatopredict-100584835","NCT06894524","Retrospective Clinical Validation of HepatoPredict","Retrospective Clinical Validation of HepatoPredict, a Prognostic Tool for Hepatic Surgery Based on a Molecular Signature","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Patients with HCC that underwent transplantation, with at least 5 years follow-up.\n* Patients with HCC that underwent surgical resection, with at least 5 years follow-up.\n* Completed informed consent process (for patient candidates that are still alive).\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old.\n* Other non-HCC liver cancers patients.\n* Patients with tumor extra-hepatic spread at diagnosis.",{"count":299,"type":21},"HepatoPredict is an innovative prognostic tool to support hepatologists, hepatobiliary surgeons and multidisciplinary teams in deciding on the best therapeutical approach for a patient with Hepatocellular Carcinoma, the most common type of primary liver cancer. HepatoPredict is a laboratory test that analyses a molecular signature from a small tumour sample and combines this information with details from imaging tests, such as the number of nodules and their size. Using a computational model, HepatoPredict determines whether a patient is likely to remain disease-free after hepatic surgery (good prognosis) or if there is a higher chance of the tumour returning (bad prognosis).\n\nCurrent selection criteria to assess the eligibility of patients with Hepatocellular Carcinoma for liver transplantation present several problems, including:\n\n1. selection of patients that will not benefit from a transplant. This could be due to recurrence of cancer or early death from another cause.\n2. exclusion of patients who could benefit from a liver transplant but are currently not eligible;\n3. increased tumor recurrence rates. Thus, improved tools that predict the likelihood of cancer coming back are needed to better assess if a patient will benefit from hepatic surgery. This will allow better use of organs, waiting list times, and improve ways of identifying the most appropriate treatments for individual patients.\n\nHepatoPredict accurately selects patients for hepatic surgery, outperforming conventional clinical criteria. In previous retrospective studies, HepatoPredict predicted successful surgery outcomes in patients who were not eligible by currently used criteria.\n\nThis study aims to retrospectively validate the prognostic tool HepatoPredict in assessing how well a patient with Hepatocellular Carcinoma performed considering recurrence-free survival (no cancer recurrence) and overall survival after 5 years follow-up after liver surgery or liver transplantation.",[27,401,402],"Liver Resection","Liver Transplantation",[404,405,401,406,407,408],"HepatoPredict","Liver Transplant","Prognosis","Hepatocellular Carcinoma (HCC)","HCC Recurrence","2025-03-18",{"date":411,"type":44},"2025-03-25",{"date":413,"type":21},"2025-03",{"date":415,"type":21},"2026-04-30",{"name":417,"class":216},"Ophiomics",{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":267},"100578495","phase-2-haic-combined-with-donafenib-and-sintilimab-as-perioperative-treatment-for-resectable-hepatocellular-carcinoma-patients-at-high-risk-of-recurrence-100578495","NCT06812039","HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence","HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence: a Prospective, Multicenter, Randomized Phase II Study","Inclusion Criteria:\n\n* Voluntary enrollment with written informed consent obtained\n* Age 18 to 75 years (inclusive), regardless of gender\n* Histologically or pathologically confirmed previously untreated hepatocellular carcinoma (HCC) or clinically diagnosed previously untreated HCC according to the AASLD guidelines.\n* Initial resectable status as assessed by the investigator (expected to achieve R0 resection, sufficient liver remnant volume, and Child-Pugh class A, as per the \"Chinese Expert Consensus on Neoadjuvant Therapy for Liver Cancer (2023 Edition)\").\n* At least one measurable lesion according to mRECIST criteria.\n* Tumor burden meets one of the following conditions:\n\n  1. A single tumor with a diameter \\> 5 cm;\n  2. Multiple tumors with the largest tumor diameter \\> 3 cm, with \\\u003C 5 tumors in total;\n  3. Presence of portal vein tumor thrombus (Vp1-Vp2).\n* Liver function: Child-Pugh score of 5-6.\n* ECOG 0-1\n* Life expectancy of at least 3 months.\n* Women of childbearing potential (defined as not postmenopausal or surgically sterilized) must have a negative serum pregnancy test within 7 days prior to the study drug administration.\n* Both women and men of childbearing potential must use reliable contraception during the study and for 60 days following the last dose of the study drug.\n* For HBV-infected patients: If HBV-DNA is ≥ 10⁴ copies\u002Fml within 14 days prior to enrollment, antiviral therapy (preferably entecavir) must be initiated to reduce HBV-DNA to \\\u003C 10⁴ copies\u002Fml before entering the study. Antiviral therapy should continue, with regular monitoring of liver function and HBV-DNA levels.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Patients with distant metastasis.\n* Patients with portal vein tumor thrombosis (Vp3-Vp4).\n* History of any other malignant tumor within the past 5 years, unless the patient has received potentially curative treatment and there is no evidence of recurrence in the past 5 years. This 5-year time requirement does not apply to patients who have successfully undergone resection for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ.\n* History or current presence of congenital or acquired immunodeficiency diseases.\n* Active or previously documented autoimmune diseases or inflammatory disorders (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, pituitary inflammation, hyperthyroidism or hypothyroidism, asthma requiring bronchodilators for treatment, etc.). Patients with vitiligo or asthma fully resolved in childhood and not requiring intervention as adults may be included.\n* History of severe psychiatric disorders.\n* Conditions affecting the absorption, distribution, metabolism, or elimination of the study drugs (e.g., severe vomiting, chronic diarrhea, bowel obstruction, malabsorption, etc.).\n* Major surgery within 4 weeks prior to enrollment (as defined by the investigator).\n* History of allogeneic stem cell or solid organ transplantation (except for corneal transplantation).\n* Received other systemic antitumor therapies (including traditional Chinese medicine with antitumor indications) within 2 weeks or 5 half-lives (whichever is longer) prior to study drug administration, or unresolved adverse events related to prior treatments that have not recovered to ≤ CTCAE Grade 1.\n* Use of systemic immunosuppressive drugs within 2 weeks prior to enrollment, or anticipated need for systemic immunosuppressive therapy during the study.\n* Concurrent use of drugs that may prolong the QTc interval and\u002For induce Tdp, or drugs affecting drug metabolism.\n* Known or suspected allergy to donafenib, recombinant humanized PD-1 monoclonal antibodies, or similar agents, or a history of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, or to excipients of the study drugs.\n* Uncontrolled hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion, or pericardial effusion.\n* Active bleeding or coagulation disorders, bleeding tendencies, or ongoing treatment with thrombolytics, anticoagulants, or antiplatelet therapy.\n* History of gastrointestinal bleeding or clear gastrointestinal bleeding tendencies within the past 6 months (e.g., known active ulcerative lesions, positive stool occult blood with ≥2+ results, requiring endoscopy if stool occult blood remains positive), or other conditions that may lead to gastrointestinal bleeding as determined by the investigator (e.g., severe esophageal\u002Fgastric varices).\n* History of gastrointestinal perforation, abdominal fistulas, or intra-abdominal abscesses within the past 6 months.\n* History of thrombosis or thromboembolic events (e.g., stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the past 6 months.\n* Significant cardiovascular disease, including but not limited to: acute myocardial infarction, severe\u002Funcontrolled angina, coronary artery bypass grafting within the past 6 months; congestive heart failure (NYHA class \\>2); poorly controlled arrhythmias requiring pacemaker treatment; drug-resistant hypertension (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg).\n* Active infection.\n* Other significant clinical or laboratory abnormalities that may affect safety evaluation, such as uncontrolled diabetes, chronic kidney disease, grade 2 or higher peripheral neuropathy (CTCAE v5.0), thyroid dysfunction, etc.\n* Use of live attenuated vaccines within 4 weeks prior to enrollment or during the study.\n* Pregnant or breastfeeding women, or women or men of childbearing potential unwilling or unable to use effective contraception.\n* History of alcohol, drug, or substance abuse within the past 6 months.\n* Participation in any other clinical trial involving investigational drugs or medical devices within 4 weeks prior to enrollment.\n* Inability to comply with the study protocol for treatment or follow-up visits.\n* Any other conditions that, in the opinion of the investigator, would preclude participation in the study.",{"count":426,"type":21},165,[87],"This study will evaluate the efficacy and safety of therapy perioperative treatment with HAIC combined with donafenib and sintilimab (group A)\u002F donafenib combined with sintilimab (group B) compared with direct surgery (group C) in resectable HCC patients who are at high risk for disease recurrence.",[27],"2025-02-05",{"date":432,"type":44},"2025-02-06",{"date":434,"type":44},"2025-01-01",{"date":436,"type":21},"2028-01-31",{"name":152,"class":76},{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":450,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":77},"100573141","phase-2-pd-l1-antibody--bevacizumab-with-hepatic-arterial-infusion-chemotherapy-for-advanced-hcc-100573141","NCT06742424","PD-L1 Antibody + Bevacizumab With Hepatic Arterial Infusion Chemotherapy for Advanced HCC","Efficacy and Safety of PD-L1 Antibody Combined With Bevacizumab and Hepatic Arterial Infusion Chemotherapy in Advanced Unresectable Hepatocellular Carcinoma With Extrahepatic Metastases: A Single-Arm, Prospective, Phase II Clinical Study","Inclusion Criteria:\n\nSigned written informed consent Histologically\u002Fcytologically confirmed hepatocellular carcinoma (HCC) or clinically diagnosed according to HCC diagnostic criteria Radiologically confirmed extrahepatic metastases with unresectable disease as evaluated by investigators No prior treatment with PD-L1 antibody and\u002For bevacizumab Age ≥18 and ≤75 years ECOG Performance Status 0-1 Child-Pugh Class A or B7 Able to comply with study protocol requirements At least one measurable or evaluable lesion according to RECIST v1.1\n\nAdequate organ and bone marrow function:\n\nAbsolute neutrophil count ≥1.5×10\\^9\u002FL Platelet count ≥75×10\\^9\u002FL Hemoglobin ≥9.0 g\u002FdL Total bilirubin ≤2×ULN ALT and AST ≤5×ULN Serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL\u002Fmin Urine protein \\\u003C2+ by dipstick APTT and INR ≤1.5×ULN Normal cardiac enzymes Normal thyroid function or on stable replacement therapy Life expectancy ≥12 weeks Effective contraception for participants of childbearing potential during treatment and for 6 months after last dose\n\nExclusion Criteria:\n\nSevere complications from liver disease (severe bleeding from portal hypertension, infection, hepatic encephalopathy) Prior systemic anti-tumor therapy for HCC Other malignancy within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ) Current participation in other interventional clinical trials Systemic treatment with Chinese herbal medicine or immunomodulators within 2 weeks before first dose Active autoimmune disease requiring systemic treatment within 2 years Systemic corticosteroid therapy within 7 days before first dose Prior allogeneic organ transplantation (except corneal) or stem cell transplantation Known allergy to monoclonal antibodies or HAIC components Inadequate recovery from prior treatment toxicities Known HIV infection Untreated active HBV infection (HBsAg positive with HBV-DNA above upper limit of normal) Active HCV infection Live vaccine administration within 30 days before first dose Pregnancy or breastfeeding\n\nSerious or uncontrolled systemic diseases including:\n\nSignificant cardiac arrhythmias or conduction abnormalities Unstable angina or NYHA class ≥2 heart failure Arterial thrombotic events within 6 months Uncontrolled hypertension Active interstitial lung disease Active tuberculosis Active systemic infections Active diverticulitis or GI obstruction Uncontrolled diabetes Significant proteinuria Psychiatric disorders affecting compliance Any condition that could interfere with study participation or interpretation of results",{"count":446,"type":21},36,[87],"This is a single-arm, phase II clinical trial evaluating the safety and efficacy of PD-L1 antibody combined with bevacizumab and hepatic arterial infusion chemotherapy (HAIC) for patients with advanced unresectable hepatocellular carcinoma (HCC) with extrahepatic metastases.\n\nStudy Population: Patients with advanced HCC who have:\n\n* Confirmed extrahepatic metastases\n* No prior PD-L1 or bevacizumab therapy\n* Age 18-75 years\n* Child-Pugh A or B7 liver function\n* ECOG performance status 0-1\n\nTreatment Regimen:\n\n* PD-L1 antibody: 1200mg every 3 weeks\n* Bevacizumab: 15mg\u002Fkg every 3 weeks\n* HAIC with FOLFOX regimen: Up to 6 cycles\n* Treatment continues until disease progression or up to 24 months\n\nPrimary Endpoint:\n\n-Objective Response Rate (ORR)\n\nSecondary Endpoints:\n\n* Disease Control Rate (DCR)\n* Duration of Response (DOR)\n* Progression-free Survival (PFS)\n* Overall Survival (OS)\n* Safety assessments\n* Quality of life measurements\n\nStudy Design Details:\n\n* Single-arm study using Simon's two-stage design\n* First stage: 27 patients\n* Second stage: 9 additional patients if first stage shows efficacy\n* Total planned enrollment: 36 patients\n* Study duration: October 2024 - July 2027\n\nThis study aims to evaluate whether adding HAIC to PD-L1 inhibitor plus bevacizumab immunotherapy can improve outcomes for advanced HCC patients with extrahepatic spread, who currently have limited treatment options. The trial will assess both efficacy and safety of this combination approach.",[27],[451,452,453,454],"HAIC","PD-L1","Bevacizumab","extrahepatic metastases","2024-12-16",{"date":457,"type":44},"2024-12-19",{"date":459,"type":44},"2024-10-01",{"date":461,"type":21},"2027-07-30",{"name":463,"class":76},"West China Hospital"]