Status:
UNKNOWN
Adjuvant PD-1 Antibody in Combination With Capecitabine for Patients With ICC at High-Risk of Postoperative Recurrence
Lead Sponsor:
Fudan University
Conditions:
Cholangiocarcinoma, Intrahepatic
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
Cholangiocarcinoma has a low incidence, accounting for only 3% of gastrointestinal malignancies worldwide, but with an increasing trend in recent years.Cholangiocarcinoma is extremely malignant, and t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04782804
Start Date
January 1 2021
End Date
May 1 2024
Last Update
August 18 2022
Active Locations (1)
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1
Lulu@Huashan.Org.Cn
Shanghai, China, 20040