A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital
About this trial
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).
Eligibility criteria
Qualifiers
Male or female aged 18-75 years;
Patients must provide signed informed consent prior to enrollment, demonstrating the ability to understand and willingness to sign the written informed consent form;
Pathologically confirmed diagnosis of intrahepatic cholangiocarcinoma;
Locally advanced disease, failure to achieve R0 resection, and absence of distant metastasis;
Disqualifiers
Pathologically diagnosed hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma, or other non-cholangiocarcinoma malignant components;
Patients with postoperative recurrence, or those who have previously received PD-1/PD-L1 antibodies, CTLA-4 antibodies, lenvatinib, or chemotherapy;
History or current diagnosis of other malignancies;
Active tuberculosis infection;
Trial design
Treatments tested in this trial
- GOLP regimen
- Surgery
- TDTP-RECIST
Treatment groups
270 Participants
are divided into 3 treatment groupsSponsors and collaborators
Shanghai Zhongshan Hospital
Lead sponsor
Shanghai Geriatric Medical Center
Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborator
Shanghai 10th People's Hospital
Collaborator
Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
Collaborator
Source ClinicalTrials.gov