Intrahepatic Cholangiocarcinoma (Icc)
Conditions
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.
Interventions
DRUGAdebrelimab
Adebrelimab administered intravenously at \[1200mg\] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.
DRUGGemcitabine
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，
DRUGCisplatin
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.
DRUGS-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.
DRUGApatinib
Apatinib administered orally at \[250mg\] once daily continuously, for up to 17 cycles, in combination with adebrelimab.
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-Free Survival (RFS) | Through study completion, an average of 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Through study completion, an average of 4 years |
Countries
China
Contacts
CONTACTBaoluhe Zhang
PRINCIPAL_INVESTIGATORShunda Du
Peking Union Medical College Hospital (PUMCH)
PRINCIPAL_INVESTIGATORMei Guan
Peking Union Medical College Hospital (PUMCH)
Outcome results
None listed