A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST (NCT07208526) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST
China270 participantsStarted 2025-12-01
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
✓. At least one measurable lesion;
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0;
✓. Child-Pugh class A liver function;
Exclusion criteria
✕. 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;
✕. Active, known, or suspected autoimmune disease;
✕. History of interstitial lung disease, or non-infectious pneumonitis requiring steroid treatment;