Actively Recruiting
Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma
Led by Zhejiang Hisun Pharmaceutical Co. Ltd. · Updated on 2025-12-30
75
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathologically confirmed advanced hepatocellular carcinoma (HCC).
- Disease progression confirmed by imaging after prior treatment with immune checkpoint inhibitors.
- Barcelona Clinic Liver Cancer (BCLC) stage B or C; not eligible for or refusing surgery or locoregional liver therapies.
- Child-Pugh class A or B liver function (score ����� 7), no history of hepatic encephalopathy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- At least one measurable extracranial lesion per RECIST version 1.1.
- Expected survival of at least 3 months.
- Availability of tissue samples confirming high AKR1C3 expression.
- Adequate organ function.
- For hepatitis B positive patients: HBV DNA level < 2000 IU/mL and ongoing anti-HBV therapy maintained throughout the study and for 6 months after last dose.
- For hepatitis C positive patients: HCV-RNA below detection limit.
- Female participants of childbearing potential must not be breastfeeding and have a negative pregnancy test within 7 days before treatment.
- Both female and male participants of childbearing potential must agree to use effective contraception during the study and for 6 months after last dose.
- Willingness to voluntarily participate and comply with study procedures.
You will not qualify if you...
- Patients with intrahepatic cholangiocarcinoma, dual-phenotype HCC, fibrolamellar HCC, or carcinosarcoma.
- Untreated active central nervous system metastases; treated and stable CNS metastases may be allowed.
- History of other cancers within 2 years except certain treated skin or in situ cancers.
- Severe cardiovascular or cerebrovascular diseases.
- Recent anti-cancer therapies or major surgery within specified washout periods.
- Participation in other clinical trials with investigational drugs within 4 weeks prior to study.
- Residual toxicities from previous treatments greater than grade 1.
- Moderate to large symptomatic pleural effusion, pericardial effusion, or ascites needing drainage.
- Need for strong CYP3A4 inhibitors or inducers during the study.
- Severe infections requiring systemic treatment at screening.
- Known HIV infection or positive syphilis test.
- Pregnancy, lactation, or plans to become pregnant.
- Concomitant diseases or physical conditions posing excessive risk or interfering with study.
- History of hypersensitivity to ethanol or propylene glycol.
- Other investigator-judged reasons making participation unsuitable.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China, 211102
Actively Recruiting
Research Team
W
WEI QU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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