Recruiting

Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study

This multicenter real-world study assesses the efficacy and safety of adjuvant therapies in postoperative intrahepatic cholangiocarcinoma (ICC) patients with high-risk recurrence factors. 90 eligible patients will be assigned to: Cohort 1: GP (gemcitabine/cisplatin) + adebrelimab Cohort 2: Apatinib + adebrelimab Cohort 3: S-1 (tegafur/gimeracil/oteracil) + adebrelimab Outcomes will be compared against historical real-world controls receiving standard chemotherapy.

ClinicalTrials.gov IDNCT07640048
PhaseNot Applicable
Enrollment90
SponsorPeking Union Medical College Hospital
Age18 Years and older
SexALL
I'm interested View official listing

Conditions studied

Intrahepatic Cholangiocarcinoma (Icc)

About this study

This multicenter real-world study assesses the efficacy and safety of adjuvant therapies in postoperative intrahepatic cholangiocarcinoma (ICC) patients with high-risk recurrence factors. 90 eligible patients will be assigned to: Cohort 1: GP (gemcitabine/cisplatin) + adebrelimab Cohort 2: Apatinib + adebrelimab Cohort 3: S-1 (tegafur/gimeracil/oteracil) + adebrelimab Outcomes will be compared against historical real-world controls receiving standard chemotherapy.

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * Histologically confirmed ICC within 12 weeks after curative resection * Any T stage; N0/N+; M0. * At least one high-risk factor: Preoperative tumor penetration of the liver capsule or extrahepatic direct invasion; Preoperative imaging showing multifocal lesions or a single lesion \>5 cm; Vascular invasion (preoperative or postoperative pathology); Regional lymph node metastasis. * No prior systemic therapy for ICC. * ECOG performance status 0-2. * Expected survival ≥3 months. * Adequate organ function. * Agreement to use effective contraception (or surgical sterilization) during the study and for 120 days after the last dose. * Signed informed consent and anticipated good compliance with the study protocol. Exclusion Criteria: * Immunosuppressive therapy within 28 days prior to enrollment (excluding topical/inhaled corticosteroids or physiologic steroid doses ≤10 mg/day prednisone equivalent). * Systemic anticancer herbs/immunomodulators (e.g., thymosin, interferons) within 4 weeks, except for pleural effusion control. * Uncontrolled cardiovascular disease: Unstable angina/myocardial infarction Arrhythmias with QTc ≥450 ms (men) or ≥470 ms (women) NYHA Class III-IV heart failure or LVEF \<50% * Active infections (IV antibiotics/antivirals required) or fever \>38.5°C within 4 weeks; or major surgery within 3 weeks. * Active autoimmune/immunodeficiency diseases (e.g., hepatitis, pneumonitis, rheumatoid arthritis), except: Hypothyroidism on stable hormone replacement Type 1 diabetes with controlled glucose Uncontrolled asthma requiring systemic bronchodilators (resolved childhood asthma allowed). \- Active infections: HIV/AIDS HBV (DNA ≥500 IU/mL) or HCV (RNA-positive) unless: HBV DNA \<500 IU/mL + antiviral therapy ≥14 days * Prior/proposed organ transplantation (excluding corneal grafts). * Concurrent interventional trials or investigational drugs within 4 weeks without recovery to Grade ≤1 toxicity. * Hypersensitivity to study drug components. * Allogeneic transplant history/plans. * Uncontrolled psychiatric/substance abuse disorders. * Refractory hypertension (≥140/90 mmHg despite treatment). * Clinically significant bleeding/thromboembolism: GI bleeding within 3 months Thrombotic events within 6 months (stroke, DVT/PE) * Coagulopathy (INR \>1.5, PT \>ULN+4s, aPTT \>1.5×ULN) or anticoagulant use. * Proteinuria ≥++ on dipstick or 24-h urine protein ≥1 g. * Other high-risk conditions per investigator judgment.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-27.