Adjuvant Therapy After Surgery for Malignant Biliary Tumors
Conditions
Interventions
Durvalumab and Capecitabine Concurrent Therapy Group:Postoperative adjuvant treatment exposure in the group receiving durvalumab combined with capecitabine concurrently
Capecitabine Group:Exposure to oral capecitabine postoperative adjuvant therapy
Capecitabine followed by Durvalumab sequential treatment group:Capecitabine and durvalumab sequential treatment group postoperative adjuvant therapy exposure
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age must be =18 years and =75 years; 2. No gender restriction; 3. Diagnostic Criteria: Participants whose diagnosis is confirmed as malignant biliary tumors through pathological examination, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder cancer; 4. Treatment History: The study participants have already undergone radical surgical treatment, with the time between the surgery and enrollment not exceeding 8 weeks; 5. Health Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 6. Survival Time: The survival time is not less than 3 months; 7. Laboratory indicators: Liver function (ALT, AST not exceeding 2.5 times the upper limit of normal, bilirubin not exceeding 1.5 times the upper limit of normal) and renal function (creatinine clearance =60 mL/min) all meet the requirements; 8. Compliance: Research participants are able to understand the study content and are willing to sign the informed consent form and follow the study protocol.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors: A history of other malignant tumors within the past 5 years, excluding cured non-melanoma skin cancer and carcinoma in situ; 2. Major complications: having severe heart disease, lung disease, extremely abnormal liver function, or any other serious organ dysfunction; ... 3. History of immunotherapy: Previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors; 4. History of chemotherapy: Received any form of chemotherapy before or after radical surgery; 5. Infection: Presence of any uncontrolled infection, including but not limited to HIV, active hepatitis B or C; 6. Mental Condition: Presence of mental illness or cognitive impairment, unable to understand the study content or comply with the study protocol; 7. Pregnant or breastfeeding women: Women who are currently pregnant, planning to become pregnant, or are breastfeeding; 8. History of drug allergies: Known allergic reactions to capecitabine, durvalumab, or any excipients used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence Rate within 6 Months;Quality of Life; | — |
Countries
China
Contacts
Public ContactJin Yanwen
West China Hospital of Sichuan University
Outcome results
None listed