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TACE+Tilelizumab+Sorafenib in the Treatment of BCLC Stage C HCC

Zhejiang University logo

Zhejiang University

Status and phase

Enrolling
Phase 2

Conditions

BCLC Stage C Hepatocellular Carcinoma

Treatments

Procedure: TACE
Drug: Tilelizumab
Drug: Sorafenib

Study type

Interventional

Funder types

Other

Identifiers

NCT04992143
HEPIC2004

Details and patient eligibility

About

According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Studies have shown that TACE combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and PD-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. Therefore, in order to improve the survival benefit of BCLC stage C liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of TACE combined with sorafenib and tislelizumab in the treatment of BCLC stage C liver cancer patients.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥18 years
  • Child-Pugh score≤ 7
  • HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2019
  • the primary HCC being in BCLC C stage according to NCCN guideline
  • No previous systemic therapy for HCC

Exclusion criteria

  • Diffuse HCC
  • Uncontrolled ascites of hepatic encephalopathy
  • Prior liver transplantation
  • Positive for human immunodeficiency virus
  • Active gastric or duodenal ulcer
  • Other uncontrolled comorbidities or malignancy

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

TACE combined Tilelizumab and Sorafenib
Experimental group
Description:
TACE first combined Tilelizumab(240mg/3wks ivgtt) and Sorafenib (800mg/day orally)
Treatment:
Drug: Tilelizumab
Procedure: TACE
Drug: Sorafenib

Trial contacts and locations

1

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Central trial contact

Tong-yin Zhu, MD; Jun-hui Sun, MD,PH.D

Data sourced from clinicaltrials.gov

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