biliary tract cancer
Conditions
Interventions
Experimental group:surufatinib combined with durvalumab and capecitabine
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects who volunteered to join the study signed the informed consent form, which showed good compliance and cooperated with the follow-up; 2. Pathological diagnosed as locally advanced/metastatic biliary tract tumors (including iCCA, pCCA, dCCA and GBC); 3. No previous systemic treatment for biliary tract cancer; 4. 18-75 years old (boundary values included); 5. At least one measurable lesion (RECIST 1.1); 6. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 (amputation patients 0-2); 7. Life expectancy > 3 months; 8. Normal major organ function was defined as the following: absolute neutrophil count = 1.5×10^9/L, platelet = 100×10^9/L, hemoglobin = 90g/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3× upper limit of normal (ULN) [if liver function is abnormal due to malignant tumor: AST and ALT = 5 × ULN], total bilirubin < 1.5×ULN, serum creatinine < 1.5×ULN; 9. Obstructive jaundice, after treatment with PTCD or ERCP, may be considered for enrollment if liver function indicators meet the requirements for enrollment; 10. Subjects of potential fertility are required to use at least one medically approved contraceptive (e.g., IUD, pill, or condom) during and for 180 days after study treatment; and must have a negative serum HCG test prior to the first dose; and the woman must be non-lactating.
Exclusion criteria
Exclusion criteria: 1. pathologic diagnosis of pancreatic cancer, jugular carcinoma or mucinous gallbladder cancer; 2. previous systemic treatment for biliary tract tumors [gemcitabine-based chemotherapy or TKI-like small molecule anti-angiogenic drug therapy or any tumor immunotherapy (e.g. PD-1/ L1 inhibitors, CTLA-4 inhibitors, etc.)]; 3. have a known allergy to any of the drugs under study 4. with a history of severe cardiovascular or cerebrovascular disease: - Cerebrovascular accident (except lacunar cerebral infarction, mild cerebral ischemia or transient ischemic attack, etc.), myocardial infarction, unstable angina, poorly controlled arrhythmia (including QTc interval = 450ms in men and = 470 ms in women) (QTc interval calculated by the Fridericia formula); - New York Heart Association (NYHA) cardiac function classification > Class II or left ventricular ejection fraction (LVEF) 1.0 g 10. a history of other malignancies within five years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin 11. the patient has any current disease or condition that interferes with drug absorption or the patient is unable to take oral sovalteinib 12. active or uncontrolled serious infections; 1) Known human immunodeficiency virus (HIV) infection; 2) Known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must be excluded from active HBV infection, i.e., positive HBV DNA (>1 x 10^4 copies/mL or >2000 IU/ml); 3) Known hepatitis C virus infection (HCV) with positive HCV RNA (>1×10^3 copies/mL), or other hepatitis, cirrhosis]; 13. subjects with symptomatic brain metastases (confirmed or suspected). 14. Subjects with any clinical or laboratory test abnormalities or other reasons that, in the opinion of the investigator, make them unsuitable for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease control rate;Relapse-free survival;Major pathological response rate;Overall survival; | — |
Countries
China
Contacts
Public ContactLiu Houbao
Shanghai Xuhui Central Hospital
Outcome results
None listed