Tislelizumab(Anti PD-1), Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer
NCT05156788 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-08-15
Summary
The aim of this study is to assess the R0 resection rate of tislelizumab combined with Lenvatinib and Gemox chemotherapy in the conversion therapy of potentially resectable locally advanced BTC.
Conditions
- Biliary Tract Cancer
- PD-1 Antibody
- Gemox
- Lenvatinib
Interventions
- DRUG
-
PD-1+Lenvatinib+GEMOX
Tilelizumab 200mg, add 0.9% NS 100mL, d1 Q3W, Lenvatinib 8mg, po, qd Gemox chemotherapy: Gemcitabine 1000mg/m2 with 0.9% NS 100mL, 30 minutes, d1, 8, Q3W, + oxaliplatin 85mg/m2 with 5%GS 500mL, 2 hours, d1, Q3W
Sponsors & Collaborators
-
Shanghai Zhongshan Hospital
lead OTHER
Principal Investigators
-
Jia Fan · Shanghai Zhongshan Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-12
- Primary Completion
- 2023-07-03
- Completion
- 2025-10-01
Countries
- China
Study Locations
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