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GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
Sponsor: Beijing Gene Key Life Technology Co., Ltd
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
GKL-006 Injection
An iNKT cell therapy
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