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RECRUITING
NCT05430698
PHASE2

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

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

This 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.

Official title: PD-1 Antibody Plus Gemcitabine and Oxaliplatin (GEMOX) as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma Patients With Positively Metastatic Lymph Nodes : a Single Arm, Phase II Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2023-01-31

Completion Date

2027-12-31

Last Updated

2026-02-09

Healthy Volunteers

No

Interventions

DRUG

PD-1antibody plus GEMOX

1. PD-1 antibody,200mg,D1,intravenous infusion, the administration time is 60 (+15) minutes. 2. GEMOX chemotherapy : gemcitabine 1000mg/m2,D1,D8;oxaliplatin 100mg/m2,D1,intravenous infusion. 3. Three weeks is a course of treatment,a total of 6-8 courses.

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China