A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST

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).

NCT Number	NCT07208526
Lead Sponsor	Shanghai Zhongshan Hospital Collaborators: Shanghai Geriatric Medical Center, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 10th People's Hospital, Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
Conditions	Intrahepatic Cholangiocarcinoma (Icc), Conversion Therapy, TDTP-RECIST, GOLP Regimen
Enrollment	270 participants
Start Date	2025-12-01
Primary Completion	2028-06-30 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-10-06