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

ConditionIntrahepatic Cholangiocarcinoma (Icc)

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

This trial does not accept healthy volunteers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Cohort 1: GP + adebrelimab3 interventions

Group B: Cohort 2: Apatinib + adebrelimab2 interventions

Group C: Cohort 3: S-1 + adebrelimab2 interventions

Trial outcomes

Primary outcomes

Recurrence-Free Survival (RFS)

Time frame

Through study completion, an average of 4 years

Secondary outcomes

Overall Survival (OS)

Time frame

Through study completion, an average of 4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov

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