SBRT Sequential TACE Combined With Sorafenib Versus Sorafenib Alone in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus：A Single-center Randomized Controlled Study

HEPIC2001

To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.

2020-04-30

2023-08-01

2023-08-01

Recruiting

Early phase I

54

Inclusion Criteria: * Age \>18 years * Child-Pugh score ≤ 7 * Performance status: ECOG score ≤ 2 * HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017 * the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline * No previous therapy for HCC * at least one measurable target lesion according to RECIST 1.1 * Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3 * Serum total bilirubin ≤ 2 x ULN * Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN * Creatinine ≤ 1.5 x ULN * No plan for pregnancy or breast feeding. Active contraception. * Willing to give informed consent Exclusion Criteria: * Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib * Complete obstruction of hepatic outflow * Uncontrolled ascites of hepatic encephalopathy * Prior liver transplantation * Positive for human immunodeficiency virus (HIV) * Active gastric or duodenal ulcer * Other uncontrolled comorbidities or malignancy * Inability to give informed consent

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 54, 'type': 'ESTIMATED'}}

2023-02-16