Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma

Summary

This study is conducted to evaluate the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of hepatic artery infusion chemotherapy (HAIC), tyrosine kinase inhibitor/ anti-VEGF antibody, and anti-PD-1/ PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation. Factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination.

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

PROCEDURE

HAIC

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.

DRUG

Bevacizumab plus Atezolizumab

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

DRUG

Bevacizumab Biosimilar IBI305 plus sintilimab

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

DRUG

Lenvatinib

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

DRUG

Sorafenib

400mg; p.o. bid

DRUG

Donafenib

200mg; p.o. bid

DRUG

Regorafenib

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

DRUG

apatinib plus camrelizumab

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

DRUG

Anti-PD-1 monoclonal antibody

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).

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

• Haplox Biotechnology Co., Ltd.

  collaborator INDUSTRY

• Geneplus-Beijing Co. Ltd.

  collaborator INDUSTRY

• The Second Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Ze-yang Ding, MD

  lead OTHER

Principal Investigators

• Wanguang Zhang, M.D. · Tongji Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-19

Primary Completion

2025-06-30

Completion

2025-12-30

Countries

• China

Study Locations