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A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST
Sponsor: Shanghai Zhongshan Hospital
Summary
This project aims to conduct a prospective, multicenter, randomized controlled clinical trial. The study plans to enroll 270 patients with locally advanced iCCA who have successfully undergone GOLP conversion therapy. Participants will be randomized at a 1:2:2 ratio into three arms: Control Arm (continued medication), Direct Surgery Arm, and TDTP-RECIST Assessment Arm. The primary endpoint is Overall Survival (OS).
Official title: A Multicenter Randomized Controlled Study on Surgical Decision-Making Guided by the TDTP-RECIST Evaluation System for Locally Advanced Intrahepatic Cholangiocarcinoma Following GOLP Conversion Therapy
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2025-12-01
Completion Date
2028-12-31
Last Updated
2025-10-06
Healthy Volunteers
No
Interventions
GOLP regimen
PD1 antibody (Toripalimab) combined with GEMOX chemotherapy and Lenvatinib neoadjuvant treatment
Surgery
R0 resection
TDTP-RECIST
Treatment selection between continued GOLP therapy and surgical R0 resection based on TDTP-RECIST criteria.
Locations (1)
Zhongshan hospital, Shanghai
Shanghai, China