Hepatocellular carcinoma
Conditions
Interventions
experimental group:sintilimab combined with sorafenib
Sponsors
The First Hospital Affliated to the USTC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HCC confirmed by histology / cytology or cirrhosis meeting the clinical diagnostic criteria of American Association for the study of liver diseases (AASLD); 2. Aged >= 18 years, males or females; 3. ECOG Performance Status of 0 or 1; 4. Advanced or unresectable or metastatic HCC patients (BCLC stage B-C stage), not suitable for local therapy or progressed after local treatments; 5. Patients who have not received systemic anti-tumor therapy for HCC before the first administration; 6. Patients with at least one measurable focus according to the evaluation standard of solid tumor efficacy version 1.1 (RECIST v1.1); 7. Child Pugh score = 12 weeks. 10. For women or men whose sexual partners are women of childbearing potential, contraceptive measures shall be taken during the whole treatment period and 6 months after the last dose administration. 11. Patients who have signed the written informed consent and are able to follow the visit and related procedures specified in the plan.
Exclusion criteria
Exclusion criteria: 1. Patients with fibrolamellar carcinoma, sarcomatoid carcinoma, cholangiocarcinoma and other components previously confirmed by histology / cytology; 2. With histories of hepatic encephalopathy or liver transplantation; 3. With clinically significant ascites; 4. Patients with acute or chronic active hepatitis B or C infection: HBV DNA>2000IU/ml or 104 copies /mL; HCV RNA>\103 copies /mL; both HbsAg; 5. With central nervous system metastasis; 6. Patients with esophageal or gastric variceal bleeding due to previous portal hypertension within 6 months. With severe varices (G3) are known to be present on endoscopy within 3 months prior to the first administration; portal hypertension (including splenomegaly found by imaging); high bleeding risk in the investigator's judgment. 7. Patients who have had any life-threatening bleeding events in the past 3 months, including the need for blood transfusion, surgery or local treatment, continuous drug treatment; 8. Patients with previous 6 months' history of thromboembolism, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism;(except thrombus of implanted vein port or catheter source or superficial vein after routine anticoagulant treatment) Prophylactic use of low-molecular-weight heparin (e.g., enoxaparin 40 mg / day) is permitted; 9. Patients with cancer thrombus of the main portal vein involving the branches of the opposite portal vein, or involving the superior mesenteric vein and inferior vena cava at the same time; 10. Patients taking aspirin (> 325 mg / day) or other drugs known to inhibit platelet function, such as dipyridamole or clopidogrel, for 10 consecutive days within 2 weeks before the first administration; 11. With inadequately controlled arterial hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic B; 12. With symptomatic congestive heart failure, Grade 3 or 4Symptomatic or poorly controlled arrhythmias, history of congenital long QT syndrome, corrected QTc > P > 100 mmHg), history of hypertensive crisis or hypertensive encephalopathy. 13. Patients with severe bleeding tendency or coagulation dysfunction or undergoing thrombolysis; 14. Patients with a history of gastrointestinal perforation and / or fistula, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea in the past 6 months; 15. Radiotherapy within 3 weeks before the first dose administration. Otherwise, all the following conditions must be met before entering the group: no toxic reaction related to radiotherapy, no need to take glucocorticoids, and no radiation pneumonia, radiation hepatitis, radiation enteritis, etc.; 16. With active or History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis , drug-related pneumonia, impairment of lung function and other lung diseases; 17. With active tuberculosis (TB), receiving antiTB treatment or received antiTB treatment within one year before the first dose administration; 18. With human immunodeficiency virus (HIV) infected (HIV 1/2 antibody positive), known syphilis infected; 19. With severe infection within 4 weeks prior to the first dose administration. including, but not limited to,ho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;DOR;TTP;TTR;OS; | — |
Countries
China
Contacts
Public ContactLianxin Liu
Anhui provincial hospital
Outcome results
None listed