Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma

The goal of this clinical trial is to learn if drug AST-3424 works to treat AKR1C3 high expressing advanced hepatocellular carcinoma after failure of systemic therapy with immune checkpoint inhibitors. The main question it aims to answer is: Does AST-3424 prolong survival in patients with AKR1C3-high Expressing advanced Hepatocellular Carcinoma who have progressed after immune checkpoint inhibitors based therapies? Researchers will compare AST-3424 to regorafenib (current optional therapy for target patients) to see if AST-3424 works. Participants will: Receive AST-3424 infusion on Day 1 a

Trial Details

NCT ID

NCT07310173

Phase

PHASE2

Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

Status

RECRUITING

Cancer Type

Liver Cancer

Interventions

AST-3424
Regorafenib Tablets

Locations (sample)

Nanjing, Jiangsu, China|32.06167,118.77778

Key Eligibility Criteria

Patients with pathologically confirmed advanced hepatocellular carcinoma (HCC).
Documented disease progression confirmed by medical imaging after failure of prior systemic therapy regimens containing immune checkpoint inhibitor…
Barcelona Clinic Liver Cancer (BCLC) stage B or C; ineligible for or refusing surgical resection or locoregional liver therapies (including transar…
Child-Pugh class A or B liver function (score ≤ 7), with no history of hepatic encephalopathy.

For full eligibility, visit ClinicalTrials.gov.

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