NCT05717738

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

Combined Transarterial Chemoembolization, Tyrosine Kinase Inhibitor/ Anti-VEGF Antibody, and Anti-PD-1/ PD-L1 Antibody as Conversion Therapy for Advanced Hepatocellular Carcinoma: a Multicenters, Real-world, Ambispective Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The multicenter, non-random, open and ambispective real-world cohort study is conducted at 4 research centers, including 3 centers (Hankou, Sino-French New District, and Optical Valley) of Tongji hospital (Wuhan, China) and one in the second affiliated hospital of Fujian Medical University (Quanzhou, China). It is estimated that 300 patients with advanced HCC will be enrolled in these 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. Radiological assessments are performed every two cycles over the course of treatment, then every 3 months within the first two years following the completion of treatment and every 6 months thereafter, until PD were recorded. All subjects are followed until death or lost to follow up.

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-20
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2023-02-08
• Last updated: 2024-06-13

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated drug study