Biliary tract neoplasms
Conditions
Interventions
treatment group:Donafenib combination with S-1
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily enroll and sign a written informed consent form; 2) Age: 18 to 80 years old (inclusive), gender not limited; 3) Patients with histological or cytological diagnosis of BTC and undergoing radical resection (R0 or R1 resection), including; Intrahepatic and extrahepatic cholangiocarcinoma, ampullary cancer or gallbladder cancer; 4) According to the 7th edition of the UICC classification, patients have a high risk of postoperative recurrence, including extrahepatic cholangiocarcinoma, gallbladder cancer, ampulla cancer (T2-4,N0,M0 or T1-4,N1,M0), and intrahepatic cholangiocarcinoma (T1-4, N0-1,M0). 5) From radical surgery to enrollment = 80 g/L Neutrophils >= 1.5×10^9/L Platelet count >= 75,000/mm 3 Biochemical examination: Total bilirubin <=3× Upper limit of normal (ULN) The aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are <= 5×ULN.
Exclusion criteria
Exclusion criteria: 1) Pancreatic cancer or mucinous gallbladder cancer confirmed by histology/cytology; 2) Having a history of other malignant tumors within 5 years prior to the enrollment trial (except for fully treated cervical carcinoma in situ or non-melanoma skin cancer); 3) Previously received drug treatments such as PD-1/L1 monoclonal antibodies, multi-kinase inhibitor drugs, and anti-VEGF monoclonal antibodies 4) Active infections requiring systemic treatment; 5) A history of severe mental illness in the past; 6) Evidence of significant clinical diseases or laboratory test results that the researcher deems unsuitable for the patient to participate in the trial; 7) Pregnant or lactating women, women of childbearing ability, and men whose partners are expected to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence free survival; | — |
Countries
China
Contacts
Public ContactDaobing Zeng
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed