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

NCT07640048 | Recruiting

• 1 other identifier: I-25PJ1046
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intrahepatic Cholangiocarcinoma (Icc)

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival (RFS)

  Through study completion, an average of 4 years

Secondary Outcomes (1)

• Overall Survival (OS)

  Through study completion, an average of 4 years

Study Arms (3)

Cohort 1: GP + adebrelimab

Drug: Adebrelimab; Drug: Gemcitabine; Drug: Cisplatin

Cohort 2: Apatinib + adebrelimab

Drug: Adebrelimab; Drug: Apatinib

Cohort 3: S-1 + adebrelimab

Drug: Adebrelimab; Drug: S-1

Interventions

Adebrelimab DRUG

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

Cohort 1: GP + adebrelimab; Cohort 2: Apatinib + adebrelimab; Cohort 3: S-1 + adebrelimab

Gemcitabine DRUG

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，

Cohort 1: GP + adebrelimab

Cisplatin DRUG

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.

Cohort 1: GP + adebrelimab

S-1 DRUG

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.

Cohort 3: S-1 + adebrelimab

Apatinib DRUG

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

Cohort 2: Apatinib + adebrelimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with intrahepatic cholangiocarcinoma (ICC) at high risk of recurrence

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital (PUMCH)

Beijing, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Interventions

Gemcitabine; Cisplatin; S 1 (combination); apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Shunda Du

  Peking Union Medical College Hospital (PUMCH)

  PRINCIPAL INVESTIGATOR

• Mei Guan

  Peking Union Medical College Hospital (PUMCH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baoluhe Zhang

CONTACT

010-69152831; dushd@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 10, 2026
• Study Start: May 4, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CN (1)