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

NCT07209813 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-08-17

No results posted yet for this 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.

Conditions

  • Hepatocellular Carcinoma (HCC)
  • Unresectable Hepatocellular Cancer

Interventions

DRUG

GKL-006 Injection

An iNKT cell therapy

PROCEDURE

TACE

A standard locoregional therapy for hepatocellular carcinoma

Sponsors & Collaborators

  • Beijing Gene Key Life Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Gaojun Teng, MD · Zhongda Hospital, South University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-14
Primary Completion
2027-09-30
Completion
2027-10-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07209813 on ClinicalTrials.gov