Biliary tract cancer
Conditions
Interventions
Experimental Group :surufatinib and toripalimab combined with gemcitabine and cisplatin
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old (including 18 and 75 years old), regardless of gender; 2. Histologically or cytologically confirmed locally advanced or metastatic unresectable cholangiocarcinoma; 3. No prior systemic therapy for unresectable, locally advanced or metastatic cholangiocarcinoma; Patients who received one regimen of adjuvant or neoadjuvant chemotherapy and relapsed more than 6 months after completion of chemotherapy were eligible for enrollment. 4. Liver function Child-Pugh A (5-6 points) or better B (=7 points); 5. ECOG score 0 or 1; 6. Expected survival =12 weeks; 7. At least one measurable lesion (RECIST 1.1 criteria); 8. The functions of major organs and bone marrow were basically normal: a) Blood routine: white blood cell = 4.0 x 10^9/L, neutrophil = 1.5 x 10^9/L, platelet = 100 x 10^9/L, hemoglobin = 90g/L; b) international normalized ratio (INR) =1.5× upper limit of normal value (ULN) and activated partial thromboplastin time (APTT) =1.5×ULN; c) Liver function: total bilirubin = 1.5x ULN; In the absence of liver metastasis, ALT/AST/ALP = 2.5x ULN; ALT/AST /ALP = 5 x ULN in patients with liver metastasis; d) renal function: serum creatinine = 1.5x ULN and creatinine clearance (CCr) > 60mL/min; e) Cardiac function: left ventricular ejection fraction (LVEF) = 50% measured by two-dimensional echocardiography. 9. Fully understand and voluntarily participate in this study, and sign informed consent; 10. Male or female patients of childbearing potential volunteered to use an effective contraceptive method during the study and for 6 months after the last study medication.
Exclusion criteria
Exclusion criteria: 1. Received approved or investigational local or systemic anti-tumor therapy within 4 weeks before enrollment, including interventional therapy, chemotherapy, biological immunotherapy, targeted therapy, etc. 2. Liver metastases of 50% or more of the total liver volume as determined by the investigator; (3) Clinically intervened biliary obstruction that was not resolved or required anti-infective treatment as judged by the investigator 14 days before the first study drug treatment; 4. Previous liver transplantation; 5. Symptomatic or previous CNS metastases: -prior systemic, definitive treatment (radiotherapy or surgery) for brain or leptomeningeal metastases, if radiographic stability has been maintained for at least 1 month and systemic hormone therapy has been discontinued (dose not more than10mg/ day prednisone or other effective hormones) for more than 2 weeks without clinical symptoms. 6. Participated in clinical trials of other drugs not yet approved or marketed in China and received treatment with corresponding trial drugs within 4 weeks before enrollment; 7. Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody; 8. Use of immunosuppressive drugs within 14 days before treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., not more than 10 mg/ day of prednisolone or another corticosteroid at the physiological dose of the drug); 9. History of autoimmune disease, idiopathic pulmonary fibrosis, interstitial lung disease, drug-induced pneumonia, idiopathic pneumonia or active pneumonia detected by chest CT scan, active tuberculosis, etc. 10. Recipients of live vaccine within 4 weeks before treatment; 11. Received anti-tumor vaccine, or received anti-tumor treatment with systemic immune stimulation; 12. Received any major surgery or invasive treatment or operation within 4 weeks before enrollment (excluding venous catheterization, puncture drainage, puncture biopsy, etc.); 13. Patients have drug-uncontrolled hypertension defined as systolic blood pressure =140mmHg and/or diastolic blood pressure =90 mmHg; 14. The patient has any current disease or condition that affects drug absorption or the patient is unable to take oral sorafenib; 15. 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 or perforation as judged by the investigators; 16. Patients with evidence or history of significant bleeding tendency within 3 months before enrollment (bleeding within 3 months> 30 mL, hematemesis, melena, hematochezia), hemoptysis (within 4 weeks > 5 mL of fresh blood) or a thromboembolic event (including a stroke event and/or transient ischemic attack) within 12 months; 17. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months before enrollment; New York Heart Association (NYHA) classification of congestive heart failure >Grade 2; Ventricular arrhythmias requiring medical therapy; Electrocardiogram (ECG) showed QTc interval =480 msec. 18. Patients with other malignant tumors in the past 5 years, excluding skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ; 19. Congenital or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression free survival;overall survival;drug safety; | — |
Countries
China
Contacts
Public ContactXuetao Shi
Shandong Cancer Hospital
Outcome results
None listed