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)
Recurrence-Free Survival (RFS) — Through study completion, an average of 4 years
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital (PUMCH)
Beijing
China
Recruiting
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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.
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