Biliary tract cancer
Conditions
Interventions
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Unresectable or metastatic advanced BTC confirmed by histology or cytology, including extrahepatic cholangiocarcinoma (EHCC), intrahepatic cholangiocarcinoma (IHCC) or gallbladder cholangiocarcinoma (GBC); 3. Previous first-line cytotoxic chemotherapy, treatment failure or intolerable toxicity; 4. Liver function Child-Pugh A (5-6 points) or better B (= 12 weeks; 7. At least one measurable lesion; 8. Main organs and bone marrow function are basically normal: (1) Blood routine: white blood cells >= 4.0 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 90g/L; (2) International normalized ratio (INR) = 50% detected by two-dimensional echocardiography; 9. Fully understand this research, participate voluntarily, and sign the informed consent; 10. Patients with reproductive potential voluntarily use effective contraceptive methods during the study period and within 6 months of the last study medication, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause, or sterilization (eg, hysterectomy, bilateral adnexectomy, or radioactive ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Received approved or under-study systemic anti-tumor therapy within 4 weeks before enrollment, including: photodynamic therapy, chemotherapy, radical radiotherapy, ablation, local radiotherapy (Palliative radiotherapy for bone metastases has been completed at least 2 weeks before study drug treatment is allowed), biological immunotherapy, targeted therapy, etc.; 2. Previously received approved or experimental anti-VEGF tyrosine kinase inhibitor or monoclonal antibody treatment; 3. The investigator determines that liver metastases account for 50% or more of the total liver volume; 4. The biliary obstruction that has undergone clinical intervention has not been relieved or needs anti-infective treatment 14 days before the first study drug treatment; 5. Have received liver transplantation in the past; 6. Suffering from untreated central nervous system metastases, who have received systemic, radical brain or meningeal metastases in the past (radiotherapy or surgery), those who have been stable for at least 1 month and have stopped systemic hormone therapy (dose >10mg/day prednisone or other equivalent efficacy hormones) for more than 2 weeks and no clinical symptoms can be included; 7. Received any surgery or invasive treatment or operation within 4 weeks before enrollment (except for venous catheterization, puncture and drainage, etc.); 8. Electrolyte abnormalities judged by the investigator to be clinically significant; 9. The patient currently has hypertension that cannot be controlled by drugs, defined as: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg; 10. The patient currently has any disease or condition that affects the absorption of the drug, or the patient cannot take surufatinib orally; 11. The patient currently has gastrointestinal diseases such as gastric and duodenal active ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator; 12. Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment (bleeding>30 mL within 3 months, hematemesis, melena, blood in stool), hemoptysis (>5 mL fresh blood within 4 weeks) or a thromboembolic event (including stroke and/or transient ischemic attack) within 12 months; 13. Cardiovascular disease with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass surgery within 6 months before enrollment; congestive heart failure New York Heart Association (NYHA) class > 2; ventricular arrhythmia requiring drug therapy; electrocardiogram (ECG) showing QTc interval >= 480 ms; 14. Suffering from other malignant tumors in the past 5 years, except for skin basal cell or squamous cell carcinoma after radical resection, or carcinoma in situ of the cervix; 15. Active or uncontrolled serious infection (>=CTC AE grade 2 infection); 16. Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis [a known carrier of hepatitis B virus (HBV) must exclude active HBV infection, i.e. positive HBV DNA (>1x10^4 copies/mL or >2000 IU/ml); known hepatitis C virus infection (HCV) and positive HCV RNA (>1x10^3 copies/mL), or other hepatitis, cirrhosis]; 17. Unrelieved toxic reactions higher than CTCAE grade 1 due to any previous anticancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 16-week progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;progression-free survival;overall survival;disease control rate;safety end point; | — |
Countries
China
Contacts
Public ContactLi Huikai
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed