Hepatocellular CarcinomaPhase 3NCT06371157
A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
A Phase 3 study testing AK104, Lenvatinib and TACE in people with Hepatocellular Carcinoma, run by Akeso at 4 sites in China.
Trial summary
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma 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, Lenvatinib and TACE
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 469 participants
- Where
- 4 sitesChina
- Study dates
- 2 Aug 2024to 23 May 2026
- 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
- Has a diagnosis of HCC confirmed by histology/cytology，or meet the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD)
- No evidence of metastasis
- Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE
- Child Pugh score class A
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- Measurable disease by RECIST 1.1
- Adequate organ function
Who cannot join
- History of liver transplantation
- History of hepatic encephalopathy
- Uncontrolled arterial hypertension
- Deep venous thrombosis within 3 months before first treatment
- Bleeding events within the last 6 months
- Co-infection with HBV and HCV
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410006
Shanzhi Gu
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Guoliang Shao
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Gaojun Teng
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450004
Hailiang Li
About this study
Official title: A Phase III, Randomized, Double-blinded, Multicenter Study of Cadonilimab (AK104) + Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
- Conditions
- Hepatocellular Carcinoma
- Being tested
- AK104, Lenvatinib, TACE, Placebo for AK104, Placebo for Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104Drug
intravenous
LenvatinibDrug
oral
TACEProcedure or surgery
TACE (chemo and embolic agent injection into the hepatic artery)
Placebo for AK104Other
intravenous
Placebo for LenvatinibOther
oral
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Receives: Drug: AK104; Drug: Lenvatinib; Procedure: TACE |
| Arm B | Placebo comparator | Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE Receives: Procedure: TACE; Other: Placebo for AK104; Other: Placebo for Lenvatinib |
| Arm C | Other | AK104 + Placebo for Lenvatinib in Combination With TACE Receives: Drug: AK104; Procedure: TACE; Other: Placebo for Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR).
Measured: Up to approximately 2 years
Secondary outcomes (6)
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 2 years
PFS per RECIST 1.1
Assessed by investigators
Measured: Up to approximately 2 years
Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Assessed by BICR and investigators
Measured: Up to approximately 2 years
Duration of Response (DOR) per RECIST 1.1 and mRECIST
Assessed by BICR and investigators
Measured: Up to approximately 2 years
Disease Control Rate (DCR) per RECIST 1.1 and mRECIST
Assessed by BICR and investigators
Measured: Up to approximately 2 years
Time to Response (TTR) per RECIST 1.1 and mRECIST
Assessed by BICR and investigators
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 posted17 Apr 2024
- Study start2 Aug 2024
- Primary completion25 Oct 2025 (estimated)
- Study completion23 May 2026 (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
- 469 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 HospitalGaojun Teng, MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371157
- Sponsor's protocol ID
- AK104-308
- Status last verified
- Mar 2025
- First submitted
- 15 Apr 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Phase III, Randomized, Double-blinded, Multicenter Study of Cadonilimab (AK104) + Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06371157
- Acronym / sponsor ID
- AK104-308
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 469 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 25 Oct 2025 (estimated)
- Study completion
- 23 May 2026 (estimated)
- First posted
- 17 Apr 2024 (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.
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AK104, Drug: Lenvatinib, Procedure: TACEAK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE) |
| Arm B | Placebo comparator | Procedure: TACE, Other: Placebo for AK104, Other: Placebo for LenvatinibPlacebo for AK104 + Placebo for Lenvatinib in Combination With TACE |
| Arm C | Other | Drug: AK104, Procedure: TACE, Other: Placebo for LenvatinibAK104 + Placebo for Lenvatinib in Combination With TACE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a diagnosis of HCC confirmed by histology/cytology，or meet the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD)
- No evidence of metastasis
- Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE
- Child Pugh score class A
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
Key exclusion criteria (6 listed)
- History of liver transplantation
- History of hepatic encephalopathy
- Uncontrolled arterial hypertension
- Deep venous thrombosis within 3 months before first treatment
- Bleeding events within the last 6 months
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 |
|---|---|---|
| AK104intravenous | Drug | Arm A, Arm C |
| Lenvatiniboral | Drug | Arm A |
| TACETACE (chemo and embolic agent injection into the hepatic artery) | Procedure or surgery | Arm A, Arm B, Arm C |
| Placebo for AK104intravenous | Other | Arm B |
| Placebo for Lenvatiniboral | Other | Arm B, Arm C |
Primary outcome
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 2 years
PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR).
6 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 2 years
PFS per RECIST 1.1
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Time frame: Up to approximately 2 years
Duration of Response (DOR) per RECIST 1.1 and mRECIST
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) per RECIST 1.1 and mRECIST
Time frame: Up to approximately 2 years
Time to Response (TTR) per RECIST 1.1 and mRECIST
Time frame: Up to approximately 2 years
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.
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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.
Guoliang Shao, MD principal investigator
Zhejiang Cancer Hospital
Gaojun Teng, MD principal investigator
Zhongda Hospital
4 sites 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, Lenvatinib and TACE in people with Hepatocellular Carcinoma, run by Akeso at 4 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 7 inclusion and 6 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 4 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. 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 (+86 (0760) 8987 3999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Up to approximately 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.