Bevacizumab in Combination With Sintilimab Versus Transcatheter Arterial Chemoembolization for the Treatment of Intermediate Stage Hepatocellular Carcinoma (Beyond Up-To-Seven Criteria)
Trial Parameters
Brief Summary
Transcatheter arterial chemoembolization (TACE) is recommended as the standard of care for patients with intermediate-stage hepatocellular carcinoma (HCC) (i.e., BCLC stage B). However, these patients is heterogeneous in terms of liver functional, tumor size and tumor number, and not all patients with mid-stage HCC will benefit from TACE. The ORIENT-32 trial confirmed the efficacy of sintilimab in combination with bevacizumab for unresectable hepatocellular carcinoma. No study has yet explored whether this regimen is appropriate for patients with BCLC stage B. The purpose of this study is to explore whether bevacizumab in combination with sintilimab is superior to conventional TACE therapy in patients with HCC with beyond-Up-to-seven criteria.
Eligibility Criteria
Inclusion Criteria: Histologically confirmed hepatocellular carcinoma, or meet the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for hepatocellular carcinoma. Age ≥ 18 years old. ECOG score 0. No systemic systemic antitumor therapy against hepatocellular carcinoma and transhepatic arterial intervention prior to treatment. Tumour extent: Barcelona Clinic Liver Cancer (BCLC) stage B unsuitable for radical surgery and/or local treatment, together with a tumour load exceeding the Up-To-Seven criteria, i.e. the sum of the size (in centimetres) of the largest tumour in the liver and the number of tumours greater than 7; tumor was bilobed with multiple lesions; at least one measurable lesion with CT/MRI showing arterial phase enhancement; no portal vein thrombus; and no extrahepatic metastasis. No risk of variceal bleeding: CT/MRI/esophagogastroduodenoscopy within 6 months did not suggest esophagogastric fundic varices and active ulcers. Child-Push