NCT05713994

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

Combined Hepatic Arterial Infusion Chemotherapy, Tyrosine Kinase Inhibitor/ Anti-VEGF Antibody, and Anti-PD-1/ PD-L1 Antibody as Conversion Therapy for Unresectable Hepatocellular Carcinoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Ze-yang Ding, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

As a local interventional treatment, hepatic arterial infusion chemotherapy (HAIC) has shown better efficacy and safety than traditional transcatheter arterial chemoembolization (TACE) in the treatment of unresectable HCC. In addition, HAIC has been widely used as an alternative to sorafenib in advanced HCC in the eastern Asia. Systemic therapies such as tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), as well as the combined use of anti-VEGF antibody and ICIs have shown promising results in the treatment of advanced HCC. Numerous studies have shown that combination therapy has a trend toward better tumor response rates, survival outcomes, and downstaging rate to monotherapy. This study is conducted by the by Chinese Collaborative Group of Liver Cancer (CCGLC), the Chinese Chapter of the International Hepato-Pancreato-Biliary Association (CC-IHPBA). It is estimated that 300 patients with advanced hepatocellular carcinoma will be enrolled in about 4 research centers. And it is planned to complete the enrollment within 1 year and it is expected that all enrolled subjects will reach the observation end point in 3 years.

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-05-19
• Primary completion: 2025-06-30
• Completion: 2025-12-30
• First posted: 2023-02-06
• Last updated: 2025-03-25

Locations

2 sites across 1 country: China