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RECRUITING
NCT07209813
PHASE2

GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma

Sponsor: Beijing Gene Key Life Technology Co., Ltd

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, open-label, controlled Phase 2 study in patients with unresectable hepatocellular carcinoma (uHCC). The purpose of this study is to compare the efficacy and safety of GKL-006 Injection in combination with transarterial chemoembolization (TACE) versus TACE alone.

Official title: A Multicenter, Randomized, Open-Label, Controlled Phase 2 Study of GKL-006 Injection in Combination With Transarterial Chemoembolization (TACE) Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-11-14

Completion Date

2027-10-31

Last Updated

2026-08-17

Healthy Volunteers

No

Interventions

DRUG

GKL-006 Injection

An iNKT cell therapy

PROCEDURE

TACE

A standard locoregional therapy for hepatocellular carcinoma

Locations (7)

302 Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Zhongda Hospital

Nanjing, Jiangsu, China

Nanjing Second Hospital

Nanjing, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China