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

Zhejiang University

Status and phase: Enrolling; Phase 3

Conditions: Portal Vein Thrombosis; Unresectable Hepatocellular Carcinoma

Treatments: Radiation: SBRT+TACE+Sorafenib; Drug: Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT04387695

HEPIC2001

Details and patient eligibility

About

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.

Full description

HCC Patients classified as BCLC stage C present with PVTT, and the recommended first-line treatment is systemic therapy with sorafenib according to updated Barcelona Clinical Liver cancer (BCLC) treatment algorithms.However, recent data from observational studies suggest that the combination of TACE and SBRT would be as effective as sorafenib.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

SBRT + TACE + Sorafenib

Experimental group

Description:

SBRT sequential TACE combined with Sorafenib

Treatment:

Radiation: SBRT+TACE+Sorafenib

Sorafenib

Active Comparator group

Description:

Sorafenib 800 mg/day orally

Treatment:

Drug: Sorafenib