Locally advanced, recurrent or metastatic tumors of the biliary system that cannot be resected surgically
Conditions
Interventions
Group 1:Surufatinib: 250 mg orally, within 1 hour after breakfast, once a day for continuous administration, and every 3 weeks as a cycle
Envolimumab: 200 mg, subcutaneous injection, on the first day and the eighth day of each cycle Day, the 15th day of administration, treatment every 3 weeks as a cycle.
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: 18-80 years old (including 18 and 80 years old); 2. Unresectable or metastatic advanced biliary system adenocarcinoma confirmed by histology or cytology, 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 unacceptable toxicity after receiving first-line standard chemotherapy; 4. Those who have received adjuvant or neoadjuvant chemotherapy of one regimen and relapse = 12 weeks; 9. At least one measurable lesion (RECIST 1.1 standard); 10. The functions of major organs and bone marrow are basically normal: (1) Blood routine: white blood cells >= 3.5 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelets >= 80 x 10^9/L, hemoglobin >= 90 g/L; (2) International normalized ratio (INR) 60 mL/min; (5) Normal heart function, left ventricular ejection fraction (LVEF) >= 50% detected by two-dimensional echocardiography; 11. Fully understand the study, participate voluntarily, and sign the informed consent; 12. Fertile male or female patients voluntarily use effective contraceptive methods during the study 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 (such as hysterectomy, bilateral adnexectomy, or radioactive ovarian irradiation, etc.).
Exclusion criteria
Exclusion criteria: 1. Received approved or under-development systemic anti-tumor therapy and local therapy for target lesions within 4 weeks before enrollment; 2. The investigator determined that liver metastases occupy 50% or more of the total liver volume; 3. The biliary obstruction after clinical intervention has not been relieved or requires anti-infection treatment 14 days before the first study drug treatment; 4. Have received liver transplantation in the past; 5. Suffering from untreated symptomatic central nervous system metastases, who have previously received systemic, radical brain or meningeal metastases treatment (radiotherapy or surgery), if imaging confirmed that the stability has been maintained for at least 1 month, and has been stopped Systemic hormone therapy (dose > 10 mg/day prednisone or other equivalent hormones) for more than 2 weeks and without clinical symptoms can be included; 6. Participated in clinical trials of other domestic unapproved or unmarketed drugs within 4 weeks before enrollment and received corresponding experimental drug treatment; 7. Received any surgery or invasive treatment or operation within 4 weeks before enrollment (except for venous catheterization, puncture and drainage, biliary stent implantation, etc.); 8. 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; 9. The patient currently has any disease or condition that affects drug absorption, or the patient cannot take Surufatinib orally; 10. Patients currently have gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding in unresected tumors, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator; 11. Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment (bleeding > 30 mL within 3 months, vomiting blood, melena, blood in stool), hemoptysis (> 5 mL fresh blood within 4 weeks); 12. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 3 months before enrollment; New York Heart Association (NYHA) grade of congestive heart failure > 2 grade; ventricular arrhythmia requiring drug treatment; electrocardiogram (ECG) showing QTc interval >= 480 milliseconds; 13. Suffering from other malignant tumors in the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical operation, or carcinoma in situ of the cervix; 14. Active or uncontrolled severe infection (>= CTCAE 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 exclude active HBV infection, that is, HBV DNA positive (> 1 × 10^4 copies/mL or > 2000 IU/ml); 16. Unresolved toxic reactions of CTCAE grade 1 or above caused by any previous anticancer treatment, excluding alopecia, lymphopenia, and = grade 2); 18. Pregnant (pregnancy test positive before medication) or women who are breastfeeding; 19. According to the investigator's judgment, there is reason to suspect that the patient has a certain disease or s
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);Drug safety; | — |
Countries
China
Contacts
Public ContactZhimin Geng
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed