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Recruiting NCT07640048

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

— Observational Intrahepatic Cholangiocarcinoma (Icc)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adebrelimab, Gemcitabine, Cisplatin, S-1.
Who it may be relevant to
Registry conditions: Intrahepatic Cholangiocarcinoma (Icc). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors

Overview

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

  • Drug Adebrelimab
    Adebrelimab administered intravenously at \[1200mg\] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.
  • Drug 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，
  • Drug 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.
  • Drug 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.
  • Drug Apatinib
    Apatinib administered orally at \[250mg\] once daily continuously, for up to 17 cycles, in combination with adebrelimab.

Primary outcome measures

  • Recurrence-Free Survival (RFS) [Time frame: Through study completion, an average of 4 years]
Secondary outcome measures (1)
  • Overall Survival (OS) [Time frame: Through study completion, an average of 4 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking Union Medical College Hospital (PUMCH) — Beijing

Identifiers

NCT: NCT07640048 · I-25PJ1046

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗