Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma

Summary

The aim of this study is to the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of transarterial chemoembolization (TACE), Anti-VEGF antibodies or pan-target anti-angiogenic drugs, and anti-PD-1/ PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation.

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

PROCEDURE

TACE

Procedure of TACE is standardized.

DRUG

Lenvatinib

8mg; p.o.; q.d.

DRUG

Anti-PD-1 monoclonal antibody

Advanced HCC Patients treated with TKI plus anti-PD-1 monoclonal antibody as systemic therapy were recruited. Anti-PD-1 monoclonal antibodies include pembrolizumab (200 mg, q3w), nivolumab (3mg/kg, q2w), camrelizumab (200mg, q2w), tislelizumab (200mg, q3w), sintilimab (200 mg, q3w), or toripalimab (240mg, q3w).

DRUG

Bevacizumab Biosimilar IBI305 plus sintilimab

Bevacizumab Biosimilar IBI305 (15mg/kg, q3w), and sintilimab (200 mg, q3w)

DRUG

Bevacizumab plus Atezolizumab

Bevacizumab (15mg/kg, q3w) plus Atezolizumab (1200 mg, q3w)

DRUG

apatinib plus camrelizumab

Apatinib(250 mg; p.o.; q. d.); camrelizumab (200 mg; iv drip; q2w)

DRUG

Sorafenib

400mg; p.o. bid

DRUG

Donafenib

200mg; p.o. bid

DRUG

Regorafenib

160 mg; p.o.; q.d.

Sponsors & Collaborators

• Chinese Cooperative Group of Liver Cancer

  collaborator OTHER

• Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province

  collaborator OTHER

• The Second Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Geneplus-Beijing Co. Ltd.

  collaborator INDUSTRY

• Haplox Biotechnology Co., Ltd.

  collaborator INDUSTRY

• Tongji Hospital

  lead OTHER

Principal Investigators

• Ze-yang Ding, M.D. · Tongji Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-20

Primary Completion

2023-12-31

Completion

2024-12-31

FDA Drug

Yes

Countries

• China

Study Locations