1014TiP - Efficacy and safety of recombinant human adenovirus type 5 injection combined with transhepatic arterial embolization sequential thermal ablation for medium-and high-risk recurrent liver cancer: a prospective, open-label, randomized controlled study

Background

Currently, 70%-80% of liver cancer patients have recurrence within 5 years after radical surgery. Therefore, determining effective treatment methods for liver cancer is still a major issue of global concern. Recombinant human adenovirus type 5 (rAd5, H101) is the world's first approved oncolytic virus product in China, rAd5 and transarterial chemoembolization (TACE) has significant anti-tumor effect in treatment of liver cancer. Compared with TACE, transhepatic arterial embolization (TAE) sequential thermal ablation may significantly improve the overall survival (OS) rate of liver cancer patients. This study aims to explore the efficacy and safety of rAd5 combined with TAE sequential thermal ablation in treatment of liver cancer, and to further explore the local and systemic immunological changes in patients.

Trial design

This is a prospective, open-label, randomized, parallel controlled study, 110 patients with medium- and high-risk recurrent liver cancer are expected to enroll. Key inclusion criteria are: age ≥18 and ≤70; ECOG performance status of 0-1; Child-Pugh score ≤7; and the expected survival time ≥3 months. All participants are randomized 1:1 to receive rAd5 combined with TAE and thermal ablation (experimental group) or TAE and thermal ablation (control group). Before, 10 mg dexamethasone was intravenously administered. rAd5 (H101) will be intratumorally injected into the hepatic segmental artery, the dosage is adjusted according to the maximum diameter of lesions: ≤10 cm, 1.0×10¹² vp/day; ≥10 cm, 1.5×10¹² vp/ day, 28 days for a cycle (4 cycles totally). 1-3 weeks after rAd5 injection and TAE or TAE, thermal ablation treatment will be performed if patients have residual tumor. Patients will be followed up at 1, 3, 6 and 12 months after treatment. The primary endpoint is objective response rate. Secondary endpoints include progression free survival, disease control rate, one-year OS and quality of life score. Exploratory endpoints are the changes from baseline in CD4+, CD8+, Treg, Th1 and Th2. The adverse events will be monitored.

Clinical trial identification

ChiCTR2300067319 (http://www.chictr.org.cn/); Release date, January 04, 2023.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.