PD-1 Antibody（Tislelizumab） Combined With Capecitabine as Adjuvant Therapy to Prevent the Recurrence in High-risk Patients With Cholangiocarcinoma After Curative Resection

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to observe the effect of PD-1 Antibody（Tislelizumab） Combined With Capecitabine as Adjuvant Therapy to Prevent the Recurrence in High-risk Patients With Cholangiocarcinoma After Curative Resection.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Antibodies; Capecitabine

Criteria

Inclusion Criteria:

• Post R0 resection, pathologically confirmed intrahepatic cholangiocarcinoma.Patients were also pathologically confirmed to have any of the following high-risk factors (ie, positive resection margins, positive lymph nodes, positive perineural invasion, and intrahepatic cholangiocarcinoma > 5cm in diameter;

• No history of any chemotherapy, radiotherapy, immunotherapy and interventional treatment prior to surgical resection;

• ECoG score 0-1 points;

• Liver function before medication child a, blood routine: WBC > 2.5 * 109 / L, PLT > 60
• 109 / L, coagulopathy: Pt prolonged < 2S, ALT < 150u / L;

• No heart, lung, or kidney function abnormalities were observed;

• No history of major bleeding disorders of the digestive tract;

• Signed informed consent;

Exclusion Criteria:

• Pregnant or lactating women.

• Patients with other malignant tumor.

• Patients with mental illness.

• Patients participated in other clinical trials in last three months.

• Residual lesions showed by Postoperative digital subtraction angiography(DSA).

• Postoperative patients treated with other targeted drugs, PD1 antibody and other immunotherapies, FOLFOX systemic chemotherapy, and HuaiErKeLi drug treatment