HCC - Hepatocellular CarcinomaPhase 2NCT07310173
Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma
A Phase 2 study testing AST-3424 and Regorafenib Tablets in people with HCC - Hepatocellular Carcinoma, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- AST-3424 and Regorafenib Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 inhibitors (ICIs).
- Barcelona Clinic Liver Cancer (BCLC) stage B or C; ineligible for or refusing surgical resection or locoregional liver therapies (including transarterial intervention and ablation).
- Child-Pugh class A or B liver function (score ≤ 7), with no history of hepatic encephalopathy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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- Expected survival ≥ 3 months.
- Availability of pathological tissue blocks or sections (including archived samples) for AKR1C3 expression and related biomarker analysis. Immunohistochemistry (IHC) results must confirm high expression of AKR1C3.
- Adequate organ function.
- For subjects positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb):
- HBV DNA level must be < 2000 IU/mL or 10⁴ copies/mL Subjects must be receiving anti-HBV therapy . This therapy must be maintained throughout the study period and for 6 months after the last dose of study drug.
- For subjects positive for HCV antibody, HCV-RNA level must be below the lower limit of detection (LLOD) of the study center.
- Female subjects of childbearing potential must be non-lactating and have a negative pregnancy test result within 7 days prior to treatment initiation. A positive urine pregnancy test result must be confirmed by a serum pregnancy test.
- Female and male subjects of childbearing potential must agree to use effective contraceptive measures from the time of study enrollment until 6 months after the last dose of study drug.
- Subjects must voluntarily participate in the study, provide written informed consent after a full understanding of the study details, and have good compliance to cooperate with study treatment, observation, and follow-up procedures.
Who cannot join
- Patients with intrahepatic cholangiocarcinoma, dual-phenotype hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, or carcinosarcoma.
- Untreated active central nervous system (CNS) metastases. Subjects with CNS metastases who have received adequate treatment, achieved stable disease for at least 4 weeks confirmed by clinical examination and brain MRI during screening, require no steroid or anticonvulsant therapy, and present no clinical symptoms may be enrolled in the study.
- A history of other malignant tumors within 2 years, except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the lung, breast, or other sites, or other tumors whose related treatments will not interfere with the safety or efficacy evaluation of the study drug.
- A history of severe cardiovascular and cerebrovascular diseases.
- Has received anti-tumor therapies including locoregional radiotherapy, chemotherapy, immunotherapy, or targeted therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; for treatment with nitrosourea or mitomycin C, a 6-week washout period is required; for oral fluoropyrimidine drugs or small-molecule targeted therapy drugs, only a 2-week washout period is needed.
- Has received major surgery other than diagnostic procedures or locoregional therapy targeting liver lesions within 4 weeks prior to the first dose.
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- Has received investigational drugs in other clinical trials within 4 weeks prior to the first dose.
- All toxicities from prior anti-cancer therapies must have resolved to ≤ grade 1 at the start of study drug administration.
- Moderate to large symptomatic pleural effusion, pericardial effusion, or ascites requiring thoracentesis/paracentesis or with a history of thoracentesis/paracentesis within 2 weeks prior to the start of study treatment. .
- Need for concomitant use of strong CYP3A4 inhibitors or inducers during the study period.
- Any severe acute or chronic infections requiring systemic antibiotic or antiviral therapy at screening.
- Known human immunodeficiency virus (HIV) infection or positive syphilis test result.
- Pregnant, lactating, or women planning to become pregnant.
- Concomitant diseases that may interfere with the conduct of the study, or physical abnormalities that the investigator deems pose an excessive risk to the subject, including but not limited to a history of significant gastrointestinal bleeding within 3 months prior to enrollment or a high risk of bleeding, active peptic ulcer, uncontrolled mental illness, or mental disorders that may interfere with the subject's understanding of the informed consent form or cooperation with treatment.
- A history of hypersensitivity to ethanol or propylene glycol.
- Other reasons judged by the investigator that make the subject unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, 211102
Chen Xun, 8625-83086666, xunchen_tys@163.com
About this study
Official title: Phase IIb, Randomized, Active-Controlled, Parallel-Group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AST-3424 in Patients With AKR1C3-High Expressing Advanced Hepatocellular Carcinoma Who Progressed After Systemic Therapy With Immune Checkpoint Inhibitors
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?
Read more
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
- HCC - Hepatocellular Carcinoma
- Being tested
- AST-3424, Regorafenib Tablets
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-3424Drug
AST-3424 is administered via intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle
Regorafenib TabletsDrug
160 mg orally, once daily for the first 21 days of each 28-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| AST3424, 4mg/m^2 | Experimental | Not described Receives: Drug: AST-3424 |
| AST3424, 6mg/m^2 | Experimental | Not described Receives: Drug: AST-3424 |
| regorafenib | Active comparator | Not described Receives: Drug: Regorafenib Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
9-month overall survival rate
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310173
- Sponsor's protocol ID
- HSE001-Ⅱ-01
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb, Randomized, Active-Controlled, Parallel-Group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AST-3424 in Patients With AKR1C3-High Expressing Advanced Hepatocellular Carcinoma Who Progressed After Systemic Therapy With Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT07310173
- Acronym / sponsor ID
- HSE001-Ⅱ-01
- Conditions
- HCC - Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AST3424, 4mg/m^2 | Experimental | Drug: AST-3424 |
| AST3424, 6mg/m^2 | Experimental | Drug: AST-3424 |
| regorafenib | Active comparator | Drug: Regorafenib Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 inhibitors (ICIs).
- Barcelona Clinic Liver Cancer (BCLC) stage B or C; ineligible for or refusing surgical resection or locoregional liver therapies (including transarterial intervention and ablation).
- Child-Pugh class A or B liver function (score ≤ 7), with no history of hepatic encephalopathy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key exclusion criteria (16 listed)
- Patients with intrahepatic cholangiocarcinoma, dual-phenotype hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, or carcinosarcoma.
- Untreated active central nervous system (CNS) metastases. Subjects with CNS metastases who have received adequate treatment, achieved stable disease for at least 4 weeks confirmed by clinical examination and brain MRI during screening, require no steroid or anticonvulsant therapy, and present no clinical symptoms may be enrolled in the study.
- A history of other malignant tumors within 2 years, except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the lung, breast, or other sites, or other tumors whose related treatments will not interfere with the safety or efficacy evaluation of the study drug.
- A history of severe cardiovascular and cerebrovascular diseases.
- Has received anti-tumor therapies including locoregional radiotherapy, chemotherapy, immunotherapy, or targeted therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; for treatment with nitrosourea or mitomycin C, a 6-week washout period is required; for oral fluoropyrimidine drugs or small-molecule targeted therapy drugs, only a 2-week washout period is needed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AST-3424AST-3424 is administered via intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle | Drug | AST3424, 4mg/m^2, AST3424, 6mg/m^2 |
| Regorafenib Tablets160 mg orally, once daily for the first 21 days of each 28-day treatment cycle. | Drug | regorafenib |
Primary outcome
9-month overall survival rate
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AST-3424 and Regorafenib Tablets in people with HCC - Hepatocellular Carcinoma, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WEI QU (8618067913551, wei.qu@hisunpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
9-month overall survival rate (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.