Biliary Tract Cancer
Conditions
Interventions
one-arm:PD-1 + Surufatinib
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 Years (concluding 18 and 75 years); 2. No previous major surgical treatment of other systems or organs or systemic antitumor therapy; 3. Pathologically confirmed Biliary tract cancer (include intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma, gallbladder carcinoma or combined hepatocellular-cholangiocarcinoma); 4. No extrahepatic metastases before resection (except lymph node metastases); 5. ECOG score 0-1; 6. Child-Pugh-A; 7. If chronic hepatitis B virus carriers: HBV DNA = 1.5 x 10^9/L (2) Platelet Count >= 75 x 10^9/L; (3) Hemoglobin >= 80 g/L; (4) Total Bilirubin (TBIL) <= 2 x ULN; (5) ALT and /or AST <= 3 x ULN; (6) Prothrombin time (PT) <= 1.5 x ULN; (7) Serum Creatinine (SCr) <= 1.5 x ULN; 9. Signed the Informed Consent Form; 10. Regardless of risk factors for recurrence;
Exclusion criteria
Exclusion criteria: 1. There are significant factors affecting oral drug absorption, or patients cannot take fruquintinib orally; 2. Active gastric and duodenal ulcer, ulcerative colitis, unresected tumor with uncontrolled hemorrhage , or other conditions that may cause GI bleeding and perforation as determined by the investigator; 3. Urinary protein >= ++, and the 24-hour urine protein quantification is greater than 1.0 g; 4. Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; Electrocardiogram (ECG) showed QTc interval >= 480 ms; 5. Other malignancy prior to study enrolment; 6. Serious infection that is uncontrolled by drug; 7. On-treatment participation in another clinical study 30 days prior to inclusion; 8. Patients considered unsuitable for inclusion in this study by the investigator; 9. The tumor was not completely resected; 10. Patients who had received anti-tumor therapy, including chemotherapy and local therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Relapse-free Survival rates at 12 month;Quality of life (EORTC QLQ-C30); | — |
Countries
China
Contacts
Public ContactZhiyong Huang
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed