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

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

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.

Conditions5

Interventions1

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