Hepatocellular CarcinomaPhase 3NCT05489289
A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection
A Phase 3 study testing AK104 in people with Hepatocellular Carcinoma, run by Akeso at 1 site in China.
Trial summary
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection. 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?
- AK104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 570 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2023to 1 Jan 2027
- Phase
- Phase 3
- 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
- Pathological diagnosis of HCC without any metastasis;
- Receiving radical resection as the only anti-tumor treatment;
- No evidence of residual cancer found during or after the operation;
- Presence of any high risk factor of postoperative recurrence;
- Child-Pugh grade: A;
- ECOG score: 0;
- Controlled underlying causes of HCC.
Who cannot join
- Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc;
- Any anti-tumor treatment other than radical surgery before randomization;
- Precarious liver function indicated by severe complications;
- Recent procedures or medications leading to high risk of bleeding;
- Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, etc;
- Failure of performing enhanced CT or MRI scans of the liver;
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- Recent severe infections or systemic antibiotics use;
- Active autoimmune diseases;
- History of other incurable malignant tumors;
- History of transplantation;
- Pregnancy.
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
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Jia Fan, Ph.D., 021-31587871, fan.jia@zs-hospital.sh.cn
About this study
Official title: A Randomized, Double-blind, Phase III Clinical Study on the Efficacy and Safety of AK104 Versus Placebo as Adjuvant Therapy for Hepatocellular Carcinoma With High Risk of Recurrence After Curative Resection
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- AK104, placebo
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104Biological
Subjects will receive AK104 until disease progression or for a maximum of 16 cycles
placeboBiological
Subjects will receive placebo until disease progression or for a maximum of 16 cycles
| Study group | Role | What they receive |
|---|---|---|
| AK104 | Active comparator | AK104 IV every three weeks Receives: Biological: AK104 |
| placebo | Placebo comparator | Placebo IV every three weeks Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival (RFS) by BICR
The time comfirmed by BICR from randomization to recurrence or death.
Measured: Up to 48 months
Secondary outcomes (5)
12-months recurrence free survival (RFS-12)
The proportion of patients without recurrence or death at 12 month.
Measured: 12 months
24-months recurrence free survival (RFS-24)
The proportion of patients without recurrence or death at 24 month.
Measured: 24 months
Time to recurrence (TTR)
The time from randomization to recurrence.
Measured: Up to 48 months
Overall survival (OS)
The time from randomization to death for any reason.
Measured: Up to 48 months
Types and proportions of adverse events (AEs)
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start5 Jan 2023
- Primary completion28 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jia Fan, Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489289
- Sponsor's protocol ID
- AK104-306
- Status last verified
- Mar 2025
- First submitted
- 4 Aug 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Phase III Clinical Study on the Efficacy and Safety of AK104 Versus Placebo as Adjuvant Therapy for Hepatocellular Carcinoma With High Risk of Recurrence After Curative Resection
- ClinicalTrials.gov ID
- NCT05489289
- Acronym / sponsor ID
- AK104-306
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 28 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 5 Aug 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.
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK104 | Active comparator | Biological: AK104AK104 IV every three weeks |
| placebo | Placebo comparator | Biological: placeboPlacebo IV every three weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathological diagnosis of HCC without any metastasis;
- Receiving radical resection as the only anti-tumor treatment;
- No evidence of residual cancer found during or after the operation;
- Presence of any high risk factor of postoperative recurrence;
- Child-Pugh grade: A;
Key exclusion criteria (11 listed)
- Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc;
- Any anti-tumor treatment other than radical surgery before randomization;
- Precarious liver function indicated by severe complications;
- Recent procedures or medications leading to high risk of bleeding;
- Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, etc;
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 |
|---|---|---|
| AK104Subjects will receive AK104 until disease progression or for a maximum of 16 cycles | Biological | AK104 |
| placeboSubjects will receive placebo until disease progression or for a maximum of 16 cycles | Biological | placebo |
Primary outcome
Recurrence free survival (RFS) by BICR
Time frame: Up to 48 months
The time comfirmed by BICR from randomization to recurrence or death.
5 secondary outcomes
12-months recurrence free survival (RFS-12)
Time frame: 12 months
24-months recurrence free survival (RFS-24)
Time frame: 24 months
Time to recurrence (TTR)
Time frame: Up to 48 months
Overall survival (OS)
Time frame: Up to 48 months
Types and proportions of adverse events (AEs)
Time frame: Up to 48 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 12 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Jia Fan, Ph.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK104 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 7 inclusion and 11 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 12 Mar 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ting Liu, M.D. ((0760)89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (RFS) by BICR (time frame: Up to 48 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 12 Mar 2025.