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NOT YET RECRUITING
NCT07208526
NA

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

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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

DRUG

GOLP regimen

PD1 antibody (Toripalimab) combined with GEMOX chemotherapy and Lenvatinib neoadjuvant treatment

PROCEDURE

Surgery

R0 resection

DIAGNOSTIC_TEST

TDTP-RECIST

Treatment selection between continued GOLP therapy and surgical R0 resection based on TDTP-RECIST criteria.

Locations (1)

Zhongshan hospital, Shanghai

Shanghai, China