intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental Group:Surufatinib combined with Toripalimab and GEMOX
Sponsors
Yichang Central People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old; 2. Advanced intrahepatic cholangiocarcinoma confirmed by histopathology or cytology; 3. No previous systemic therapy (including chemotherapy, immunotherapy, and small molecule targeted therapy); If adjuvant therapy is given after surgery, Patients who progressed >6 months after completion of adjuvant therapy (chemotherapy or radiotherapy) were eligible for enrollment. 4. Liver function Child-Pugh class A (5-6 points) or B (=7 points); 5. ECOG score of 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 are basically normal: a) Blood routine: white blood cell count = 3.5x 109/L, Absolute neutrophil count = 1.5x 109/L, blood platelet count = 75x 109/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: Serum total bilirubin = 1.5x ULN; Alanine transaminase (ALT) and/or Aspartate transferase (AST)= 2.5x ULN without liver metastasis; ALT/AST /ALP = 5 x ULN with liver metastasis; d) Renal function: serum creatinine = 1.5x ULN and creatinine clearance rate (CCr) > 60mL/min; e) normal cardiac function, left ventricular ejection fraction (LVEF) = 50% measured by two-dimensional echocardiography. 9. Fully understand this study, voluntarily participate, and sign informed consent. 10. Male or female patients of childbearing potential voluntarily use an effective method of contraception, such as dual barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. during the study and for 6 months after the last study medication. "All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnophorectomy, or radioactive ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Received approved or investigational systemic anti-tumor therapy, including 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. Have untreated central nervous system metastases, -Prior systemic, radical treatment (radiotherapy or surgery) for brain or meningeal metastases, if radiographically confirmed stability has been maintained for at least 1 month and systemic hormone therapy has been discontinued (dose>10mg/ day prednisone or other effective hormones) for more than 2 weeks without clinical symptoms are allowed. 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. Received any surgery or invasive treatment or operation within 4 weeks before enrollment (except venous catheterization, puncture drainage, etc.); 8. Electrolyte abnormalities that were judged by the investigator to be clinically significant; 9. Patients have drug-uncontrolled hypertension defined as systolic blood pressure =160 mmHg and/or diastolic blood pressure =90 mmHg; 10. The patient has any current disease or condition that affects drug absorption, or the patient is unable to take oral Surufatinib; 11. Patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases, or unresected tumor with active bleeding, or other conditions that may cause gastrointestinal bleeding or perforation determined by the investigator; 12. 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 fresh blood) or a thromboembolic event (including a stroke event and/or transient ischemic attack) within 12 months; 13. 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. 14. Other malignant tumors in the past 5 years, excluding basal cell or squamous cell carcinoma of the skin after radical resection, or carcinoma in situ of the cervix; 15. Severe active or uncontrolled infection (=CTC AE grade 2 infection); 16. Known human immunodeficiency virus (HIV) infection; Known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e., HBV DNA positive (> 1×104 copies/ml or>2000 IU/ml); known hepatitis C virus (HCV) infection with positive HCV RNA (>1×103 copies /mL), or other hepatitis, cirrhosis]; 17. Unmitigated toxic effects higher than CTCAE grade 1 due to any previous anticancer therapy, excluding alopecia, lymphopenia, and grade =2 neurotoxicity due to oxaliplatin; 18. Symptomatic peripheral neuropathy (CTCAE grade =2); 19. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 20. Any other medical conditi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;objective response rate;disease control rate;Drug safety; | — |
Countries
China
Contacts
Public ContactQiao Huang
Yichang Central People's Hospital
Outcome results
None listed