Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:Surufatinib plus sintilimab
Sponsors
Third Affiliated Hospital of the Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up; 2. Inoperable or advanced liver cancer (hepatocellular carcinoma) confirmed by clinical imaging, histopathology or cytology; 3. Male or female between the ages of 18 and 75 (including boundary values); 4.ECOG score: 0-1; Expected survival =12 weeks; 5. Liver function Child-Pugh grade A; Total bilirubin 35 g/L; 6. No history of allergy to sofantinib and its components; 7. Advanced liver cancer patients who had previously received first-line systemic therapy based on Sindilizumab combined with bevacizumab bioanalogues failed (patients who were also combined with local therapy were excluded); 8. At least one measurable lesion (according to RECIST 1.1); Magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement were used to accurately measure the diameter of the lesion =1cm, and the target lesion had not received local treatment (including but not limited to HIAC, radiofrequency ablation, argon-helium knife, radiation therapy and other local treatments) within 3 months before the study was enrolled. 9. No serious organic diseases of heart, lung, brain and other organs; 10. The main organs and bone marrow functions are basically normal: a) Blood routine: white blood cells = 4.0 x 109/L, neutrophils = 1.5 x 109/L, platelet = 80 x 109/L, hemoglobin = 90g/L; b) International Standardized ratio (INR) and activated partial thromboplastin time (APTT) =1.5× upper limit of normal (ULN); c) Liver function: serum total bilirubin = 2 x ULN; ALT/AST = 2 x ULN; Serum albumin =28g/L; d) Renal function: serum creatinine = 1.5 x ULN or eGFR=60%, creatinine clearance (CCr) =60mL/min; To rule out urinary system infection, urine routine showed urine protein < 2+, =2+ patients should be collected 24 hours of urine protein volume < 1g; e) Normal cardiac function with left ventricular ejection fraction (LVEF)=50% as measured by two-dimensional echocardiography; 11. Fertile male or female patients voluntarily used effective contraceptive methods, such as double barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and within 6 months of the last study dose. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause, or sterilization (such as hysterectomy, bilateral adnexectomy, or irradiation of radioactive ovaries).
Exclusion criteria
Exclusion criteria: 1) Patients who have participated in other anti-tumor drug clinical trials within 4 weeks prior to enrollment; 2) Patients who have undergone or are planned to undergo organ transplantation; 3) Patients with obstructive jaundice whose bilirubin reduction has not met expectations; 4) Patients who have had other malignant tumors within the past 5 years, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ; 5) Patients who have had or currently have brain metastases; 6) Patients who have taken strong inducers or inhibitors of CYP3A4 within 2 weeks prior to the first study drug administration; 7) Patients who have undergone any surgery (except biopsy) or invasive treatment or procedures within 4 weeks prior to enrollment, and the surgical incision has not completely healed (except for venous catheterization, puncture drainage, etc.); 8) Patients with clinically significant electrolyte abnormalities as judged by the investigator; 9) Patients with uncontrolled hypertension, defined as systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 10) Patients with urine routine test showing urine protein =2+, and 24-hour urine protein >1.0g; 11) Patients who, as judged by the investigator, are at high risk of tumor invasion into vital vessels causing fatal hemorrhage during the subsequent study period; 12) Patients with evident evidence or history of bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months, with hematemesis, melena, hematochezia), hemoptysis (>5 mL of fresh blood within 4 weeks); patients with hereditary or acquired bleeding disorders or coagulation dysfunction. Patients who have had clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, bleeding gastric ulcer, etc.; 13) Patients with clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure with New York Heart Association (NYHA) classification >2; ventricular arrhythmias requiring medical treatment; electrocardiogram (ECG) showing QTc interval =480 milliseconds; 14) Patients with active or uncontrolled severe infections (=CTCAE Grade 2 infection); 15) Patients with unresolved toxicity reactions higher than CTCAE Grade 2 due to any previous anti-cancer treatment, excluding alopecia, lymphocyte reduction, and neurotoxicity =Grade 2 caused by oxaliplatin; 16) Pregnant women (positive pregnancy test before drug administration) or lactating women; 17) Patients with any other diseases, clinically significant metabolic abnormalities, abnormal physical examination findings, or abnormal laboratory test results, which, as judged by the investigator, provide reasonable suspicion that the patient has a disease or condition unsuitable for the use of the study drug (such as epileptic seizures requiring treatment), or may affect the interpretation of study results, or place the patient at high risk; 18) Known human immunodeficiency virus (HIV) infection; known clinically significant history of liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must be excluded from active HBV infection, i.e., HBV DNA positive (>1×103 copies/mL), or other hepatitis, cirrhosis; 19) Patients with any active, known, or suspec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactRuoyu Wang
Third Affiliated Hospital of the Naval Medical University
Outcome results
None listed