GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
GKL-006 Injection: An iNKT cell therapy
TACE: A standard locoregional therapy for hepatocellular carcinoma
Study 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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) Assessed by Independent Review Committee Based on mRECIST — Up to approximately 18 months
Progression-free survival is defined as the time from randomization to the first documented disease progression assessed by the independent review committee (IRC) according to mRECIST, or death from any cause, whichever occurs first.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| 302 Hospital | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Recruiting |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | Recruiting |
| Zhongda Hospital | Nanjing | Jiangsu | Recruiting |
| Nanjing Second Hospital | Nanjing | Jiangsu | Recruiting |
| Jiangxi Cancer Hospital | Nanchang | Jiangxi | Recruiting |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | Recruiting |
More Beijing Gene Key Life Technology Co., Ltd trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07209813 on ClinicalTrials.gov ↗ ← All trials in China