Hepatocellular carcinoma
Conditions
Interventions
Experimental group:TACE plus tislelizumab
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with hepatocellular carcinoma confirmed by histology/cytology, or the cirrhotic patients who met the AASLD criteria for the diagnosis of hepatocellular carcinoma; 2. CNLC stage-I/II (equal to BCLC stage-A/B) patients without macrovascular invasion or extrahepatic metastasis, intrahepatic lesions are technically unresectable but still possess the possibility of conversion to resection. Intrahepatic lesions are evaluated by MDT as unresectable due to some factors: bulky tumors, tumor location near the liver hilum, chronic liver diseases, insufficient future liver remnant, difficult to achieve R0 resection, etc; 3. Aged >= 18 years; 4. Child-Pugh score = 1.5 x 10^9/L, PLT >= 75 x 10^9/L, Hb >= 90g/L; (2) Albumin >= 28g/L, TBil 50 ml/min; (4) INR = 3 months; 9. Female participants must have negative blood pregnancy tests within three days before enrollment and agree to take effective contraceptive measures during the clinical study period till 120 days after the last medication; 10. Participants must sign informed consent and comply with the follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Diffused hepatocellular carcinoma (extensive intrahepatic metastasis); 2. A history of hepatic encephalopathy or liver transplantation; 3. A history of anti-HCC treatments within one year prior to enrollment; 4. Acute or chronic active HBV or HCV infection; 5. Child-Pugh grade C patients, and Child-Pugh grade B patients who require major resection (>=3 couinaud segments); 6. A history of esophageal and gastric varices bleeding caused by portal hypertension within the past 6 months, severe varicose veins (G3) detected by endoscopy within 3 months prior to initial administration, portal hypertension patients who have a high risk of bleeding; 7. A history of arteriovenous thromboembolism within six months, including myocardial infarction, unstable angina, cerebrovascular accidents, transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism, implantable venous infusion port thrombosis, catheter-derived thrombosis, or superficial venous thrombosis. After the treatment of conventional anticoagulant therapy, patients with stable thrombosis are allowed to be enrolled. Prophylactic use of low molecular weight heparin is permitted; 8. Symptomatic congestive heart failure, poorly controlled arrhythmias, congenital long QT syndrome and adjusted QTc > 500ms; 9. Patients with severe bleeding tendency or coagulopathy, and those who are undergoing thrombolytic therapy; 10. A history of gastrointestinal perforation, fistula, intestinal obstruction, extensive small bowel resection with chronic diarrhea, Crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months; 11. Patients who receive radiotherapy within 3 weeks prior to enrollment. Patients who receive radiotherapy more than 3 weeks prior to enrollment must meet the following requirements to be enrolled: no radiation-related toxicity, no need to take glucocorticoids, and no clue of radiation hepatitis, radiation pneumonia or radiation enteritis; 12. Active tuberculosis patients who are receiving anti-tuberculosis treatment; 13. Active or uncontrollable severe infections; 14. Serious comorbidities or underlying diseases that may cause patients unable to tolerate surgery; 15. A history of other primary malignancies; 16. Persons infected with human immunodeficiency virus (HIV) (hiV1/2 antibody positive) and known to be treated for syphilis infection; 17. Known or suspected allergy to the study drug or to any study-related drugs; 18. Patients who are assessed by investigators to be not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;overall survival;disease-free survival;Progression-Free Survival;objective remission rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactSun Hongcheng
Shanghai General Hospital
Outcome results
None listed