PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma
NCT05430698 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2026-02-09
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.
Conditions
- Perihilar Cholangiocarcinoma
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.
Sponsors & Collaborators
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
lead OTHER
Principal Investigators
-
Chao Liu, PhD · Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-31
- Primary Completion
- 2027-01-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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