Hepatocellular Carcinoma (HCC)Phase 2NCT06851104
A Prospective Study of Cadonilimab in Hepatocellular Carcinoma After Radical Surgery With High Risk of Recurrence
A Phase 2 study testing Cadonilimab (AK104) in people with Hepatocellular Carcinoma (HCC), run by Guangxi Medical University at 1 site in China.
Trial summary
This study aims to compare the safety and tolerability of cadonilimab applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrent factors. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Cadonilimab (AK104)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2025to 31 Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign a written informed consent before the implementation of any trial-related procedures.
- Male or female, aged ≥18 years and ≤70 years.
- ECOG PS score is 0 - 1 point.
- Subjects diagnosed with hepatocellular carcinoma by imaging criteria and/or pathology and who have received curative resection.
- The definition of curative resection complies with the definition of curativeness in the 2024 edition of the Chinese Guidelines for Primary Liver Cancer (CNLC).
- The postoperative recurrence risk stratification conforms to the high - risk group in the ERASL - pre or ERASL - post formula.
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- No prior systemic antitumor treatment for hepatocellular carcinoma has been received.
- Child - Pugh liver function score of grade A or B7.
- Expected survival time > 6 months.
Who cannot join
- Previously diagnosed by histology/cytology, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
- Subjects with other malignant tumors within 5 years before enrollment, except for HCC. Subjects with other malignant tumors that have been cured by local treatment are not excluded, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast.
- History of hepatic encephalopathy or liver transplantation.
- Portal vein trunk or mesenteric superior vein, inferior vena cava tumor thrombus.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the safety and tolerability of cadonilimab applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrent factors.
Read the detailed description
Hepatectomy and local ablation are the main curative treatment methods for hepatocellular carcinoma, but the 5-year recurrence rate after surgery is as high as 70%, which is the main bottleneck problem affecting the long-term prognosis of patients. This study aims to investigate the safety and tolerability of cadonilimab (PD-1/cytotoxic T lymphocyte antigen-4 (CTLA-4) bispecific antibody) applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrence factors.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Cadonilimab (AK104)
- Keywords
- hepatocellular carcinoma, hepatectomy, adjuvant, cadonilimab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab (AK104)Drug
Patients with hepatocellular carcinoma after curative hepatectomy would receive cadonilimab 10 mg/kg intravenous infusion (dissolved in 0.9% NaCl 250 mL, within 60 minutes) Q3W, until disease progression, death, intolerance to toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or termination of treatment for other reasons specified in the protocol. The maximum treatment duration for cadonilimab is 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients with hepatocellular carcinoma after curative hepatectomy would receive cadonilimab 10 mg/kg intravenous infusion (dissolved in 0.9% NaCl 250 mL, within 60 minutes) Q3W, until disease progression, death, intolerance to toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or termination of treatment for other reasons specified in the protocol. The maximum treatment duration for cadonilimab is 6 months. Receives: Drug: Cadonilimab (AK104) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
the recurrence-free survival would be calculated and compared among different groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start16 Feb 2025
- Primary completion15 Sep 2025
- Study completion31 Dec 2025
Why it stopped: The support from the relevant company was not obtained as planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with hepatocellular carcinoma after curative hepatectomy would be suggested to receive cadonilimab 10 mg/kg intravenous infusion (dissolved in 0.9% NaCl 250 mL, within 60 minutes) Q3W, until disease progression, death, intolerance to toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or termination of treatment for other reasons specified in the protocol. The maximum treatment duration for cadonilimab is 6 months.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Hong Zhong, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851104
- Sponsor's protocol ID
- PREVENT-3
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Further enquiries can be directed to the corresponding author.
Publications
Yuan G, Chen Y, Zhu P, Deng Q, Su K, Liu J, Wang Y, Li R, Li W, Zang M, Hu X, Wang JJ, Li Q, Du Y, Chen J. Cadonilimab (PD-1/CTLA-4) in combination with lenvatinib in unresectable hepatocellular carcinoma (uHCC): A retrospective real-world study. Heliyon. 2024 Sep 16;10(19):e37616. doi: 10.1016/j.heliyon.2024.e37616. eCollection 2024 Oct 15.
PubMed 39398001Wu X, Sun Y, Yang H, Wang J, Lou H, Li D, Wang K, Zhang H, Wu T, Li Y, Wang C, Li G, Wang Y, Li D, Tang Y, Pan M, Cai H, Wang W, Yang B, Qian H, Tian Q, Yao D, Cheng Y, Wei B, Li X, Wang T, Hao M, Wang X, Wang T, Ran J, Zhu H, Zhu L, Liu X, Li Y, Chen L, Li Q, Yan X, Wang F, Cai H, Zhang Y, Liang Z, Liu F, Huang Y, Xia B, Qu P, Zhu G, Chen Y, Song K, Sun M, Chen Z, Zhou Q, Hu L, Abulizi G, Guo H, Liao S, Ye Y, Yan P, Tang Q, Sun G, Liu T, Lu D, Hu M, Wang ZM, Li B, Xia M. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024 Oct 26;404(10463):1668-1676. doi: 10.1016/S0140-6736(24)02135-4. Epub 2024 Oct 16.
PubMed 39426385
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Cadonilimab in Hepatocellular Carcinoma After Radical Surgery With High Risk of Recurrence
- ClinicalTrials.gov ID
- NCT06851104
- Acronym / sponsor ID
- PREVENT-3
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- hepatocellular carcinoma, hepatectomy, adjuvant, cadonilimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The support from the relevant company was not obtained as planned
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 16 Feb 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 Feb 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.
This study aims to compare the safety and tolerability of cadonilimab applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrent factors.
Detailed description
Hepatectomy and local ablation are the main curative treatment methods for hepatocellular carcinoma, but the 5-year recurrence rate after surgery is as high as 70%, which is the main bottleneck problem affecting the long-term prognosis of patients. This study aims to investigate the safety and tolerability of cadonilimab (PD-1/cytotoxic T lymphocyte antigen-4 (CTLA-4) bispecific antibody) applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrence factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with hepatocellular carcinoma after curative hepatectomy would be suggested to receive cadonilimab 10 mg/kg intravenous infusion (dissolved in 0.9% NaCl 250 mL, within 60 minutes) Q3W, until disease progression, death, intolerance to toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or termination of treatment for other reasons specified in the protocol. The maximum treatment duration for cadonilimab is 6 months.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Cadonilimab (AK104)Patients with hepatocellular carcinoma after curative hepatectomy would receive cadonilimab 10 mg/kg intravenous infusion (dissolved in 0.9% NaCl 250 mL, within 60 minutes) Q3W, until disease progression, death, intolerance to toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or termination of treatment for other reasons specified in the protocol. The maximum treatment duration for cadonilimab is 6 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign a written informed consent before the implementation of any trial-related procedures.
- Male or female, aged ≥18 years and ≤70 years.
- ECOG PS score is 0 - 1 point.
- Subjects diagnosed with hepatocellular carcinoma by imaging criteria and/or pathology and who have received curative resection.
- The definition of curative resection complies with the definition of curativeness in the 2024 edition of the Chinese Guidelines for Primary Liver Cancer (CNLC).
Key exclusion criteria (4 listed)
- Previously diagnosed by histology/cytology, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
- Subjects with other malignant tumors within 5 years before enrollment, except for HCC. Subjects with other malignant tumors that have been cured by local treatment are not excluded, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast.
- History of hepatic encephalopathy or liver transplantation.
- Portal vein trunk or mesenteric superior vein, inferior vena cava tumor thrombus.
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 |
|---|---|---|
| Cadonilimab (AK104)Patients with hepatocellular carcinoma after curative hepatectomy would receive cadonilimab 10 mg/kg intravenous infusion (dissolved in 0.9% NaCl 250 mL, within 60 minutes) Q3W, until disease progression, death, intolerance to toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or termination of treatment for other reasons specified in the protocol. The maximum treatment duration for cadonilimab is 6 months. | Drug | Treatment arm |
Primary outcome
Recurrence-free survival
Time frame: 2 years
the recurrence-free survival would be calculated and compared among different groups.
Results and safety
The study was stopped early (reason given: The support from the relevant company was not obtained as planned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 39398001Yuan G, Chen Y, Zhu P, Deng Q, Su K, Liu J, Wang Y, Li R, Li W, Zang M, Hu X, Wang JJ, Li Q, Du Y, Chen J. Cadonilimab (PD-1/CTLA-4) in combination with lenvatinib in unresectable hepatocellular carcinoma (uHCC): A retrospective real-world study. Heliyon. 2024 Sep 16;10(19):e37616. doi: 10.1016/j.heliyon.2024.e37616. eCollection 2024 Oct 15.
- Background: PubMed 39426385Wu X, Sun Y, Yang H, Wang J, Lou H, Li D, Wang K, Zhang H, Wu T, Li Y, Wang C, Li G, Wang Y, Li D, Tang Y, Pan M, Cai H, Wang W, Yang B, Qian H, Tian Q, Yao D, Cheng Y, Wei B, Li X, Wang T, Hao M, Wang X, Wang T, Ran J, Zhu H, Zhu L, Liu X, Li Y, Chen L, Li Q, Yan X, Wang F, Cai H, Zhang Y, Liang Z, Liu F, Huang Y, Xia B, Qu P, Zhu G, Chen Y, Song K, Sun M, Chen Z, Zhou Q, Hu L, Abulizi G, Guo H, Liao S, Ye Y, Yan P, Tang Q, Sun G, Liu T, Lu D, Hu M, Wang ZM, Li B, Xia M. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024 Oct 26;404(10463):1668-1676. doi: 10.1016/S0140-6736(24)02135-4. Epub 2024 Oct 16.
- Individual participant dataSharing planned: Yes. Further enquiries can be directed to the corresponding author.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cadonilimab (AK104) in people with Hepatocellular Carcinoma (HCC), run by Guangxi Medical University 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 9 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Feb 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 was stopped early (reason given: The support from the relevant company was not obtained as planned). Results are not available in the source record.
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?
Recurrence-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06851104, which also lists 2 linked publications.
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 18 Feb 2026.