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

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

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.

This Phase 2 study is designed to evaluate a treatment strategy that combines noval immune cell therapy GKL-006 Injection with standard care as TACE in patients with uHCC. Eligible participants will be enrolled at multiple study centers and randomly assigned to receive either GKL-006 Injection in combination with TACE or TACE alone.

TACE will be performed in accordance with the study protocol and institutional practice. Participants in the combination group will receive GKL-006 Injection in addition to TACE as specified in the protocol.

During the study, participants will undergo scheduled clinical evaluations, laboratory tests, imaging assessments, and safety monitoring. Tumor status will be assessed by investigators and Independent Review Committee (IRC). Safety information, including adverse events, laboratory abnormalities, and clinically significant findings, will be collected throughout treatment and follow-up.

The study is intended to characterize the clinical activity and tolerability of the combination regimen compared with TACE alone and to provide supportive evidence for further development of GKL-006 Injection in uHCC.

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.