Hepatocellular CarcinomaPhase 2NCT05432492
A Study of AK112 in Patients With Unresectable Hepatocellular Carcinoma (HCC)
A Phase 2 study testing AK112 in people with Hepatocellular Carcinoma, run by Akeso at 1 site in China.
Trial summary
Phase II open label, multicenter study to evaluate the efficacy and safety of AK112 (PD-1/VEGF Bispecific) in patients with unresectable hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- AK112
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2022to 14 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- 18 to 75 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have a life expectancy of at least 3 months.
- BCLC stage B or C, not amenable to curative surgery.
- Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
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- At least one measurable untreated lesion.
- Child-Pugh class A.
- Has adequate organ function.
- All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
Who cannot join
- With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
- History of malignancy other than HCC within 5 years, except that basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Have a history of hepatic encephalopathy or have a history of liver transplantation.
- With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
- Central nervous system (CNS) metastasis or meningeal metastasis.
- Prior immunotherapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
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- Prior systemic bevacizumab and its analogues treatment.
- Severe bleeding tendency or coagulation dysfunction; occurred arteriovenous thromboembolic events or bleeding events due to esophageal and/or gastric varices within 6 months before the first administration.
- Known presence or history of required hormone treatment interstitial lung disease or non-infectious pneumonitis.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has undergone major surgery within 30 days prior to the first dose of study treatment.
- History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of AK112 (PD-1/VEGF Bispecific) in Patients With Unresectable Hepatocellular Carcinoma (HCC)
Phase II open label, multicenter study to evaluate the efficacy and safety of AK112 (PD-1/VEGF Bispecific) in patients with unresectable hepatocellular carcinoma (HCC).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- AK112
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112Drug
IV infusion, specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects receive AK112 on Day 1 of every 3-week cycle (Q3W) until progression. Receives: Drug: AK112 |
| Cohort 2 | Experimental | Subjects receive AK112 on Day 1 of every 3-week cycle (Q3W) until progression. Receives: Drug: AK112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Adverse Events (AEs)
Measured: Up to approximately 2 years
Objective Response Rate (ORR) Per RECIST v1.1
Measured: Up to approximately 2 years
Objective Response Rate (ORR) Per mRECIST
Measured: Up to approximately 2 years
Secondary outcomes (5)
Disease control rate (DCR)
Measured: Up to approximately 2 years
Duration of Response (DoR)
Measured: Up to approximately 2 years
Time to response (TTR)
Measured: Up to approximately 2 years
Progression free survival (PFS)
Measured: Up to approximately 2 years
Overall survival (OS)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start3 Aug 2022
- Primary completion30 Apr 2025
- Study completion14 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jingfeng Liu, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432492
- Sponsor's protocol ID
- AK112-207
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2022
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of AK112 (PD-1/VEGF Bispecific) in Patients With Unresectable Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT05432492
- Acronym / sponsor ID
- AK112-207
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 14 Jun 2025 (actual)
- First posted
- 27 Jun 2022 (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.
Phase II open label, multicenter study to evaluate the efficacy and safety of AK112 (PD-1/VEGF Bispecific) in patients with unresectable hepatocellular carcinoma (HCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: AK112Subjects receive AK112 on Day 1 of every 3-week cycle (Q3W) until progression. |
| Cohort 2 | Experimental | Drug: AK112Subjects receive AK112 on Day 1 of every 3-week cycle (Q3W) until progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- 18 to 75 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have a life expectancy of at least 3 months.
- BCLC stage B or C, not amenable to curative surgery.
Key exclusion criteria (13 listed)
- With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
- History of malignancy other than HCC within 5 years, except that basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Have a history of hepatic encephalopathy or have a history of liver transplantation.
- With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
- Central nervous system (CNS) metastasis or meningeal metastasis.
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 |
|---|---|---|
| AK112IV infusion, specified dose on specified days | Drug | Cohort 1, Cohort 2 |
Primary outcome
Number of patients with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) Per RECIST v1.1
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) Per mRECIST
Time frame: Up to approximately 2 years
5 secondary outcomes
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of Response (DoR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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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. This study is not recruiting at the moment.
Jingfeng Liu principal investigator
Fujian Cancer Hospital
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 AK112 in people with Hepatocellular Carcinoma, run by Akeso 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 10 inclusion and 13 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: finished, as of the sponsor's last update on 4 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Adverse Events (AEs) (time frame: Up to approximately 2 years). The study lists 3 primary outcomes in all. 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 4 Mar 2026.