Status:
NOT_YET_RECRUITING
A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Shanghai Geriatric Medical Center
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Conditions:
Intrahepatic Cholangiocarcinoma (Icc)
Conversion Therapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 co...
Detailed Description
Intrahepatic cholangiocarcinoma (iCCA) is a highly aggressive malignancy with a poor prognosis, and a majority of patients are ineligible for curative surgery upon initial diagnosis. Although the GOLP...
Eligibility Criteria
Inclusion
- \-
- Subjects eligible to participate in this study must meet all of the following 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
- \-
- Subjects who meet any of the following exclusion criteria are not permitted to enroll in this study:
- 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;
- Significant clinically significant bleeding symptoms within 3 months prior to enrollment, or clear bleeding tendency;
- Suspected allergy to the investigational drug(s).
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT07208526
Start Date
December 1 2025
End Date
December 31 2028
Last Update
October 6 2025
Active Locations (1)
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1
Zhongshan hospital, Shanghai
Shanghai, China, 200032