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Recruiting Phase 2

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

NCT07209813 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-11-14
Last updated
2026-08-17

Condition(s) studied

Hepatocellular Carcinoma (HCC)Unresectable Hepatocellular Cancer

Investigational drug(s) / intervention(s)

GKL-006 Injection →TACE

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Main Inclusion Criteria: * Voluntarily participates in the study and provides written informed consent. * Male or female, age ≥ 18 and ≤ 80 years old * Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma. * Has CNLC stage II to IIIa disease. * Has at least one measurable lesion according to mRECIST. * Child-Pugh class A or B. * ECOG performance status of 0 - 2. * Adequate hematologic and organ function. Main Exclusion Criteria: * Has a known allergy to the investigational product or related components, including human serum albumin and IL-2. * Has another incurable malignancy within 5 years before screening or concurrently. * Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma. * Has received therapy aim to target lesion(s) within 12 weeks before screening. * Has hepatic encephalopathy within 4 weeks before screening. * Has clinically symptomatic ascites or pleural effusion requiring drainage, or has undergone thoracic or abdominal fluid drainage. * Has other active disease.

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)

FacilityCityRegionStatus
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
Official registry record

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