Adjuvant PD-1 Antibody in Combination With Capecitabine for Patients With ICC at High-Risk of Postoperative Recurrence
Cholangiocarcinoma, Intrahepatic
About this trial
This is an interventional prevention trial for Cholangiocarcinoma, Intrahepatic focused on measuring Cholangiocarcinoma, PD1, adjuvant therapy
Eligibility 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
Sites / Locations
- Lulu@Huashan.Org.CnRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Capecitabine
Capecitabine+PD-1 Antibody(Tislelizumab)
Capecitabine as Adjuvant Therapy Oral capecitabine (1250 mg/m²) was given post operatively twice a day on days 1 to 14 of a 3-weekly cycle for 24 weeks (eight cycles), and observation commenced within 16 weeks of surgery.
Capecitabine+PD-1 Antibody(Tislelizumab)as Adjuvant Therapy Oral capecitabine (1250 mg/m²) was given post operatively twice a day on days 1 to 14 of a 3-weekly cycle for 24 weeks (eight cycles), and observation commenced within 16 weeks of surgery. PD-1 Antibody(Tislelizumab, 200mg) was given q3w iv.