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OncoMatch/Clinical Trials/NCT07310173

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

Is NCT07310173 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including AST-3424 and Regorafenib Tablets for hcc - hepatocellular carcinoma.

Phase 2RecruitingZhejiang Hisun Pharmaceutical Co. Ltd.NCT07310173Data as of Jun 2026Location: China

Treatment: AST-3424 · Regorafenib TabletsThe 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 and Day 8 of each 21-day treatment cycle or take regorafenib once a day on Day 1 -Day 21 of each 28-day treatment cycle.

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Extracted eligibility criteria

Treatments studied

Other

AST-3424Regorafenib Tablets

Cancer type

Hepatocellular Carcinoma

Biomarker criteria

Required: AKR1C3 high expression (high)

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

Min 1 prior line

Must have received: immune checkpoint inhibitor

Lab requirements

Liver function

child-pugh class a or b liver function (score ≤ 7), with no history of hepatic encephalopathy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07310173 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received immune checkpoint inhibitor.

Does this trial require AKR1C3?

Yes, AKR1C3 high expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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