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OncoMatch/Clinical Trials/NCT05430698

PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma

Is NCT05430698 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies PD-1antibody plus GEMOX for perihilar cholangiocarcinoma.

Phase 2RecruitingSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNCT05430698Data as of May 2026

Treatment: PD-1antibody plus GEMOXThis is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: gemcitabine-based chemotherapy

Have used gemcitabine-based chemotherapy within 6 months

Cannot have received: anti-PD-1 therapy

have used PD-1 monoclonal antibody ... within 6 months

Cannot have received: anti-PD-L1 therapy

have used ... PD-L1 monoclonal antibody treatment within 6 months

Lab requirements

Blood counts

Neutrophils ≥ 1.5*10^9/L; platelets ≥ 100*10^9/L; hemoglobin ≥ 9g/dl; serum albumin ≥ 3g/dl

Kidney function

Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula)

Liver function

Bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 3 times the upper limit of normal; Child-Pugh score A period

The functional indicators of important organs meet the following requirements ... Child-Pugh score A period

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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