[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647027":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":24,"responsibleParty":42,"collaborators":24,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":24,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":24,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":24,"overallStatus":63,"whyStopped":24,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":24},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HAIC + DEB-TACE + Toripalimab + Lenvatinib","EXPERIMENTAL","Participants receive a combination regimen consisting of:\n\nHAIC (Hepatic Arterial Infusion Chemotherapy): Oxaliplatin 85 mg\u002Fm² and gemcitabine (total 1000 mg\u002Fm², with a portion used for DEB-TACE loading) administered via hepatic artery infusion on Day 1 of each 21-day cycle, for up to 6 cycles.\n\nDEB-TACE (Drug-Eluting Beads Transarterial Chemoembolization): Small-sized (40-90 μm) drug-eluting beads loaded with gemcitabine, performed on Day 1 of each cycle as needed (required in Cycle 1, thereafter based on tumor vascularity and imaging assessment).\n\nToripalimab: 200 mg intravenous infusion on Day 1 of each 21-day cycle.\n\nLenvatinib: Oral daily dosing (8 mg\u002Fday for body weight \\\u003C60 kg; 12 mg\u002Fday for body weight ≥60 kg), continued throughout the study.\n\nAfter completion of up to 6 cycles, patients without disease progression enter a maintenance phase receiving toripalimab plus lenvatinib until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to t",[13,14,15,16,17],"Device: DEB-TACE","Drug: Toripalimab","Drug: Lenvatinib","Drug: Gemcitabine","Drug: Oxaliplatin",[19,25,30,34,38],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","DEB-TACE","Small-sized (40-90 μm) drug-eluting beads loaded with gemcitabine, administered via transarterial chemoembolization into the hepatic artery to occlude tumor blood vessels and deliver localized chemotherapy. Performed on Day 1 of each 21-day cycle as needed (required in Cycle 1, thereafter based on tumor vascularity and imaging assessment).",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DRUG","Toripalimab","200 mg administered as an intravenous infusion on Day 1 of each 21-day cycle. Toripalimab is a humanized anti-PD-1 monoclonal antibody that blocks PD-1\u002FPD-L1 interaction, restoring T-cell anti-tumor immune activity.",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":24},"Lenvatinib","Oral daily dosing: 8 mg\u002Fday for body weight \\\u003C60 kg; 12 mg\u002Fday for body weight ≥60 kg. Lenvatinib is a multi-target tyrosine kinase inhibitor that inhibits VEGFR1-3, FGFR1-4, PDGFRα, KIT, and RET, thereby reducing tumor angiogenesis and suppressing tumor cell proliferation.",[9],{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":24},"Gemcitabine","Total dose 1000 mg\u002Fm² administered via hepatic artery infusion (HAIC) on Day 1 of each 21-day cycle, for up to 6 cycles. A portion of the dose is used for DEB-TACE drug loading; the remainder is administered via HAIC. Gemcitabine is a pyrimidine nucleoside analog that inhibits DNA synthesis and induces tumor cell apoptosis.",[9],{"type":26,"name":39,"description":40,"armGroupLabels":41,"otherNames":24},"Oxaliplatin","85 mg\u002Fm² administered via hepatic artery infusion (HAIC) on Day 1 of each 21-day cycle, for up to 6 cycles. Oxaliplatin is a third-generation platinum-based chemotherapeutic agent that forms DNA crosslinks, blocking DNA replication and transcription, and inducing tumor cell apoptosis.",[9],{"type":43,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100647027","phase-2-haic--deb-tace--toripalimab--lenvatinib-for-unresectable-intrahepatic-cholangiocarcinoma-100647027",false,"NCT07685535","HAIC + DEB-TACE + Toripalimab + Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma","Hepatic Arterial Infusion Chemotherapy (HAIC) Sequential Small-Sized Drug-Eluting Beads Transarterial Chemoembolization (DEB-TACE) Combined With Toripalimab and Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma: A Phase II Clinical Study","Inclusion Criteria:\n\n1. Voluntary participation and signed informed consent.\n2. Age 18 to 85 years.\n3. Pathologically confirmed intrahepatic cholangiocarcinoma.\n4. Imaging-confirmed unresectable locally advanced intrahepatic cholangiocarcinoma with measurable lesions (longest diameter ≥10 mm) per RECIST 1.1.\n5. No distant organ metastases (excluding lymph node metastases).\n6. Child-Pugh liver function grade A or good B (≤7 points).\n7. ECOG performance status score 0-1 within 1 week before enrollment.\n8. Expected survival ≥12 weeks.\n9. No prior treatment with immune checkpoint inhibitors (including PD-1\u002FPD-L1 antibodies and CTLA-4 inhibitors).\n10. Laboratory values within 7 days before enrollment meeting the following criteria:\n\nANC ≥1.0×10⁹\u002FL; platelets ≥50×10⁹\u002FL; hemoglobin ≥90 g\u002FL (without transfusion or G-CSF within 14 days before screening).\n\nSerum albumin ≥30 g\u002FL; total bilirubin ≤1.5×ULN; ALT and AST ≤5×ULN; serum creatinine ≤1.5×ULN or CrCl \\>50 mL\u002Fmin (Cockcroft-Gault formula).\n\nINR ≤2.3 or PT prolonged ≤6 seconds above normal range.\n\nUrine protein \\\u003C2+ (if ≥2+, 24-hour quantification \\\u003C1.0 g allowed).\n\nExclusion Criteria:\n\n1. Received other local treatments (excluding surgery) within 1 month before study entry. Prior TAE\u002FTAI not allowed. Prior TACE \\>3 times not allowed.\n2. Prior systemic anti-tumor therapy (including targeted therapy, immunotherapy, chemotherapy).\n3. Concurrent or prior other malignancy within 5 years.\n4. Active autoimmune disease or history of autoimmune disease with potential relapse.\n5. Clinically symptomatic moderate-to-severe ascites requiring therapeutic paracentesis\u002Fdrainage or Child-Pugh score \\>2; uncontrolled or moderate-to-large pleural\u002Fpericardial effusion.\n6. History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months before study treatment.\n7. History of thrombosis or embolic events (e.g., cerebrovascular accident including TIA, cerebral hemorrhage, cerebral infarction, pulmonary embolism) within 6 months before study treatment.\n8. Known inherited or acquired bleeding disorder or thrombotic tendency; currently or recently (within 10 days) receiving full-dose anticoagulants or thrombolytics for therapeutic purposes (prophylactic low-dose aspirin or LMWH allowed).\n9. Major vascular disease within 6 months before study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis).\n10. Severe, non-healing, or dehisced wounds, active ulcers, or untreated fractures.\n11. Major surgery within 4 weeks before study treatment (excluding diagnostic) or anticipated need for major surgery during the study.\n12. History of intestinal obstruction or clinical signs\u002Fsymptoms of GI obstruction within 6 months before study treatment.\n13. History of hepatic encephalopathy.\n14. Palliative radiotherapy for non-target lesions allowed only if completed ≥2 weeks before study treatment and AEs recovered to ≤CTCAE grade 1.\n15. Severe infection within 4 weeks before study treatment, including hospitalization for infection, bacteremia, or severe pneumonia; oral or IV therapeutic antibiotics within 2 weeks (prophylactic allowed).\n16. Congenital or acquired immunodeficiency (e.g., HIV infection).\n17. Palliative radiotherapy involving \\>5% of bone marrow area within 4 weeks for patients with bone metastases.\n18. Received live attenuated vaccine within 28 days before study treatment, or expected to receive such vaccine during toripalimab treatment or within 60 days after last dose.\n19. Received other investigational drugs within 28 days before study treatment.\n20. Other factors judged by the investigator that may affect study results or cause premature termination, such as alcoholism, drug abuse, other serious diseases (including psychiatric) requiring concomitant treatment, severe laboratory abnormalities, family or social factors affecting patient safety.","ALL","18 Years","85 Years",{"count":55,"type":56},29,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","Purpose: This phase II clinical trial evaluates whether a combination of liver-directed local therapies (HAIC and DEB-TACE) with immunotherapy (toripalimab) and targeted therapy (lenvatinib) is safe and effective for patients with unresectable intrahepatic cholangiocarcinoma (a type of liver cancer that cannot be removed by surgery).\n\nParticipants: Adults aged 18-85 years with pathologically confirmed unresectable intrahepatic cholangiocarcinoma, no prior immune checkpoint inhibitor therapy, and adequate organ function.\n\nStudy details include:\n\nStudy Duration: Up to 24 months per participant\n\nTreatment Duration: Up to 6 cycles (each cycle is 21 days) of combination therapy, followed by maintenance therapy with toripalimab and lenvatinib until disease progression or unacceptable toxicity\n\nVisit Frequency: Every 3 weeks during the treatment phase; tumor imaging assessments every 6-8 weeks\n\nPrimary endpoints: Objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Safety will be assessed by monitoring adverse events graded according to NCI-CTCAE v5.0.\n\nToripalimab and lenvatinib are not available through an expanded access program.",[62],"Liver Cancer","NOT_YET_RECRUITING","2026-06-28",{"date":66,"type":67},"2026-07-06","ACTUAL",{"date":69,"type":56},"2026-06-30",{"date":71,"type":56},"2028-12-31",{"name":5,"class":6}]