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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

PD-1antibody plus GEMOX

Cancer type

Cholangiocarcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT05430698 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior gemcitabine-based chemotherapy, anti-PD-1 therapy, anti-PD-L1 therapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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