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

Zhejiang University logo

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)

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

Trial contacts and locations

1

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Central trial contact

Jun-hui Sun, MD,PH.D; Tan-yang Zhou, MD,PH.D

Data sourced from clinicaltrials.gov

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