Biliary Tract Carcinoma
Conditions
Interventions
study group:surufatinib, po. qd, q3w
toripalimab, i.v. d1, q3w
chemotherapy, as per investigator's choice
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 80 year-old (including 18 and 80 years); 2. Histologically or cytologically confirmed surgically unresectable or metastatic advanced biliary tract adenocarcinoma, including extrahepatic cholangiocarcinoma (EHCC), intrahepatic cholangiocarcinoma (IHCC), or gallbladder cancer (GBC); 3. Patients with locally advanced or recurrent metastatic disease who have failed, progressed, or have intolerable toxicity to first-line standard chemotherapy; patients who have received one regimen of adjuvant or neoadjuvant chemotherapy and have recurrence = 12 weeks; 8. At least one measurable lesion (RECIST 1.1 criteria, see Appendix 2); 9. Basically normal function of main organs and bone marrow: (1) Blood routine: WBC >= 3.5 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelet >= 80 x 10^9/L, hemoglobin >= 90 g/L; (2) International normalized ratio (INR) = 50% measured by two-dimensional cardiac ultrasound. 10. Fully understand the study, volunteer to participate, and sign the informed consent form. 11. Male or female patients of childbearing potential voluntarily use effective contraceptive methods during the study and within 6 months after the last dose of study drug, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered to be of childbearing potential unless they are postmenopausal, have undergone artificial menopause, or have been surgically sterilized (e.g., hysterectomy, bilateral adnexectomy, or radiation ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Received approved or ongoing systemic anti-tumor therapy and local therapy for target lesions within 4 weeks before enrollment; 2. Liver metastases accounting for 50% or more of the total liver volume determined by the investigator; 3. Biliary obstruction after clinical intervention has not been relieved or requires anti-infective treatment as judged by the investigator 14 days before the first study drug treatment; 4. Previous liver transplantation; 5. With untreated symptomatic central nervous system metastases, Patients who previously received systemic, radical treatment (radiotherapy or surgery) for brain or meningeal metastasis, and were confirmed to be stable by imaging for at least 1 month, and those who had stopped systemic hormone therapy (dose > 10 mg/day prednisone or other effective hormones) for more than 2 weeks and had no clinical symptoms were included 6. Participated in other domestic drug clinical trials that have not been approved or marketed and received the corresponding experimental drug treatment within 4 weeks before enrollment; 7. Any surgical or invasive treatment or operation (except venous catheterization, puncture drainage, biliary stent implantation for jaundice reduction therapy, etc.) within 4 weeks before the start of enrollment; 8. Patients with uncontrolled hypertension, defined as systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg; 9. Patients with any disease or condition affecting drug absorption, or patients can not take oral sovatinib; 10. Patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation according to the Investigator; 11. Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding > 30 mL, hematemesis, melena, hematochezia), hemoptysis (> 5 mL of fresh blood within 4 weeks); 12. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 3 months prior to enrollment; congestive heart failure New York Heart Association (NYHA) class > 2; ventricular arrhythmia requiring medication; QTc interval >= 480 msec on electrocardiogram (ECG); and 13. Other malignancies within the past 5 years, except for basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ; 14. Active or uncontrolled serious infection (>= CTC AE grade 2 infection); 15. Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., HBV DNA positive (> 1 × 10^4 copies/mL or > 2000 IU/ml); 16. Unresolved toxicity of greater than CTCAE Grade 1 due to any prior anticancer treatment, excluding alopecia, lymphopenia, and neurotoxicity =2); 18. Pregnant (positive pregnancy test before medication) or lactating women; 19. In the judgment of the investigator, there is reason to suspect that the patient has a disease or condition (e.g., has a seizure and requires treatment) that is not suitable for the study drug, or that will affect the interpretation of the study results,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;disease control rate, DCR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactSuo Aili/ Yang Chengcheng
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed