SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Treatments: Sorafenib

Criteria

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