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Clinical Trials in China / NCT07640048
Recruiting Observational

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

NCT07640048 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Observational
Started
2025-05-04
Last updated
2026-06-10

Condition(s) studied

Intrahepatic Cholangiocarcinoma (Icc)

Investigational drug(s) / intervention(s)

Adebrelimab →Gemcitabine →Cisplatin →S-1 →Apatinib →

Adebrelimab: Adebrelimab administered intravenously at \[1200mg\] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.

Gemcitabine: Gemcitabine administered intravenously at \[1000 mg/m\^2\] on days 1 and 8 of each \[21\]-day cycle, for up to 8 cycles, in combination with cisplatin and adebrelimab,

Cisplatin: Cisplatin administered intravenously at \[25 mg/m\^2\] on days 1 and 8 of each \[21\]-day cycle, for up to 8 cycles, in combination with gemcitabine and adebrelimab.

S-1: S-1 (tegafur/gimeracil/oteracil) administered orally twice daily on days 1-14 of each 21-day cycle, dosed according to body surface area, for up to 8 cycles, in combination with adebrelimab.

Apatinib: Apatinib administered orally at \[250mg\] once daily continuously, for up to 17 cycles, in combination with adebrelimab.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital (PUMCH) Beijing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07640048 on ClinicalTrials.gov ↗ ← All trials in China