Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
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 criteria
Qualifiers
Histologically confirmed ICC within 12 weeks after curative resection
Any T stage; N0/N+; M0.
No prior systemic therapy for ICC.
ECOG performance status 0-2.
Disqualifiers
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.
Active infections (IV antibiotics/antivirals required) or fever >38.5°C within 4 weeks; or major surgery within 3 weeks.
Prior/proposed organ transplantation (excluding corneal grafts).
Trial design
Treatments tested in this trial
- Adebrelimab
- Gemcitabine
- Cisplatin
- S-1
- Apatinib
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov