Unresectable, Non-metastatic Hepatocellular CarcinomaPhase 2NCT05319431
A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
A Phase 2 study testing AK104, Lenvatinib and TACE in people with Unresectable, Non-metastatic Hepatocellular Carcinoma, run by Akeso at 5 sites in China.
Trial summary
To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable, Non-metastatic Hepatocellular Carcinoma
- What is being tested?
- AK104, Lenvatinib and TACE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesChina
- Study dates
- 28 Jun 2022to 30 Jun 2025
- 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
- Signed written informed consent form voluntarily.
- Histologically or cytologically documented hepatocellular carcinoma.
- CNLC IIa IIb or IIIa
- The main portal vein was not completely obstructed,
- Child-Pugh A or B
- At least one measurable lesion according to RECIST criteria
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- ECOG PS 0-1
- Adequate organ function
- Estimated life expectancy of ≥3 months
- For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent
Who cannot join
- Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc
- For HCC lesions ≥ 10 cm in any dimension, imaging evaluation showed that there were more than 10 lesions
- The main portal vein and the left and right primary branches were clogged with cancer thrombus
- History of hepatic encephalopathy or liver transplantation
- Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
- Occurred arteriovenous thromboembolic events within 6 months before the first administration.
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- Inadequately controlled hypertension.
- Attack of symptomatic congestive heart failure (LVEF<50%); History of congenital long QT syndrome.
- Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
- Severe infections.
- Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
- Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
- Unable to receive an enhanced CT or MRI scan of the liver.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The First Hospital of Beijing University
Beijing, Beijing Municipality, 100034
Hunan Cancer Hospital
Changsha, Hunan, 410013
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Shandong Cancer Hospital
Jinan, Shandong, 250117
Henan Cancer Hospital
Zhengzhou, Henan, 450003
About this study
Official title: An Open Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AK104 Plus Lenvatinib and TACE in the Treatment of Unresectable, Non-metastatic Hepatocellular Carcinoma
To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic hepatocellular carcinoma
- Being tested
- AK104, Lenvatinib, TACE
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 24 months
LenvatinibDrug
Subjects will receive lenvatinib until disease progression or for a maximum of 24 months
TACEProcedure or surgery
On demand TACE
| Study group | Role | What they receive |
|---|---|---|
| AK104+Lenvatinib+TACE | Experimental | Participants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study. Receives: Biological: AK104; Drug: Lenvatinib; Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, which ever occurs first.
Measured: Up to 2 years
Secondary outcomes (4)
Objective response rate (ORR
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
Measured: Up to 2 years
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
Measured: Up to 2 years
Duration of response (DoR)
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Measured: Up to 2 years
Number of participants with adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: the time of informed consent signed through 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start28 Jun 2022
- Primary completion15 Aug 2023
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable, Non-metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guoliang Shao, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319431
- Sponsor's protocol ID
- AK104-216
- Status last verified
- Mar 2025
- First submitted
- 1 Apr 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AK104 Plus Lenvatinib and TACE in the Treatment of Unresectable, Non-metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05319431
- Acronym / sponsor ID
- AK104-216
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 8 Apr 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.
To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic hepatocellular carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK104+Lenvatinib+TACE | Experimental | Biological: AK104, Drug: Lenvatinib, Procedure: TACEParticipants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent form voluntarily.
- Histologically or cytologically documented hepatocellular carcinoma.
- CNLC IIa IIb or IIIa
- The main portal vein was not completely obstructed,
- Child-Pugh A or B
Key exclusion criteria (13 listed)
- Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc
- For HCC lesions ≥ 10 cm in any dimension, imaging evaluation showed that there were more than 10 lesions
- The main portal vein and the left and right primary branches were clogged with cancer thrombus
- History of hepatic encephalopathy or liver transplantation
- Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
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 24 months | Biological | AK104+Lenvatinib+TACE |
| LenvatinibSubjects will receive lenvatinib until disease progression or for a maximum of 24 months | Drug | AK104+Lenvatinib+TACE |
| TACEOn demand TACE | Procedure or surgery | AK104+Lenvatinib+TACE |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 2 years
Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, which ever occurs first.
4 secondary outcomes
Objective response rate (ORR
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of response (DoR)
Time frame: Up to 2 years
Number of participants with adverse events (AEs)
Time frame: the time of informed consent signed through 90 days after the last dose
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: 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. This study is not recruiting at the moment.
Guoliang Shao, MD principal investigator
Zhejiang Cancer Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK104, Lenvatinib and TACE in people with Unresectable, Non-metastatic Hepatocellular Carcinoma, run by Akeso at 5 sites 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: under way, not looking for participants, 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 5 sites 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?
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?
Progression-free survival (PFS) (time frame: Up to 2 years). 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.