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

Prior treatment

• Patients with postoperative recurrence, or those who have previously received PD-1/PD-L1 antibodies, CTLA-4 antibodies, lenvatinib, or chemotherapy;
• Significant clinically significant bleeding symptoms within 3 months prior to enrollment, or clear bleeding tendency;
• Suspected allergy to the investigational drug(s).

Other illness

• Pathologically diagnosed hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma, or other non-cholangiocarcinoma malignant components;
• 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;

Other

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• Subjects who meet any of the following exclusion criteria are not permitted to enroll in this study:

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• 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;