Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study
A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors
Peking Union Medical College Hospital
90 participants
May 4, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria21
- 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.
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Interventions
Adebrelimab administered intravenously at \[1200mg\] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.
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 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 (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 administered orally at \[250mg\] once daily continuously, for up to 17 cycles, in combination with adebrelimab.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07640048