Hepatocellular CarcinomaNCT05221398
Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Guangxi Medical University at 1 site in China.
Trial summary
Though hepatectomy is one of the curative treatment for patients with hepatocellular carcinoma (HCC), the 5-years recurrence-free survival is lower than 30%. In recent years, several immune checkpoint inhibitors have been approved in advanced 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?
- Immune Checkpoint Inhibitors Based Adjuvant therapy and Active surveillance
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2019to 30 Dec 2030
- Phase
- Observational
- 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
Study population: Patients with hepatocellular carcinoma who underwent curative hepatectomy. And then, these patients receive adjuvant immune checkpoint inhibitors therapy or active surveillance.
Who may be able to join
- Underwent curative hepatectomy;
- Diagnosis of HCC was confirmed by postoperative histopathology;
- Liver function Child-Pugh A or B;
- Performance status score 0 or 1
- With high risk factor of HCC recurrence, such as tumor size ≥ 5 cm, multinodular, macrovascular invasion or microvascular invasion;
Who cannot join
- Receive neoadjuvant immune checkpoint inhibitors therapy.
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
Jian-Hong Zhong
Nanning, Guangxi, 530021
Jian-Hong Zhong, PhD, +86 15296561499, zhongjianhong@gxmu.edu.cn
About this study
Official title: Adjuvant Immune CheckPoint InhibitoRs Based ThErapy in PostoperatiVe HEpatocellular CarciNoma: a ProspecTive Real-world Study
Though hepatectomy is one of the curative treatment for patients with hepatocellular carcinoma (HCC), the 5-years recurrence-free survival is lower than 30%. In recent years, several immune checkpoint inhibitors have been approved in advanced HCC. However, no study about the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with HCC after hepatectomy was reported.
Read the detailed description
Hepatic resection is one of the curative treatment for patients with early stage hepatocellular carcinoma (HCC) or selected intermediate or advanced disease. However, the postoperative 5-years recurrent rate is up to 70%, for whom recurrence is a major cause of death. In recent years, several immune checkpoint inhibitors have been approved in advanced HCC by official guidelines. At the same time, four randomizead controlled trials about adjuvant immune checkpoint inhibitors for postoperative HCC are ongoing. However, no study about the safety and efficacy of adjuvant immune checkpoint inhibitors for such patients in clinical practice was reported. Therefore, the investigators plan to investigate the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with high-risk factor of HCC recurrence after curative hepatectomy in a prospective cohort study with real word clinical data.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Immune Checkpoint Inhibitors Based Adjuvant therapy, Active surveillance
- Keywords
- immune checkpoint inhibitor, adjuvant
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Checkpoint Inhibitors Based Adjuvant therapyDrug
Patients in this group will recieve immune checkpoint inhibitors based adjuvant therapy
Active surveillanceOther
Patients in this group only receive active surveillance
| Study group | Role | What they receive |
|---|---|---|
| Immune checkpoint inhibitors based adjuvant therapy | Patients in this arm will receive immune checkpoint inhibitors based adjuvant therapy. Receives: Drug: Immune Checkpoint Inhibitors Based Adjuvant therapy | |
| Without adjuvant therapy | Patients in this arm will not receive any adjuvant therapy. Receives: Other: Active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survivial
Recurrence-free survival is calculated from the date of liver resection to the date of tumor recurrence or death from any cause, whichever occurred first.
Measured: 1 year
Secondary outcomes (1)
Overall survival
Overall survival is calculated from the date of liver resection to the date of death from any cause or the date of the last follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start3 Mar 2019
- Primary completion18 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
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
- NCT05221398
- Sponsor's protocol ID
- PREVENT-1
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yopp A, Chen M, Cheng AL, Kaseb A, Kudo M, Lee HC, Cha E, Hack SP, Lian Q, Spahn J, Wu C, Qin S, Chow PK. Updated data from IMbrave050: Adjuvant atezolizumab plus bevacizumab for high-risk hepatocellular carcinoma. J Hepatol. 2026 Jun;84(6):1102-1111. doi: 10.1016/j.jhep.2026.01.006. Epub 2026 Jan 22.
PubMed 41580093Qin S, Chen M, Cheng AL, Kaseb AO, Kudo M, Lee HC, Yopp AC, Zhou J, Wang L, Wen X, Heo J, Tak WY, Nakamura S, Numata K, Uguen T, Hsiehchen D, Cha E, Hack SP, Lian Q, Ma N, Spahn JH, Wang Y, Wu C, Chow PKH; IMbrave050 investigators. Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Nov 18;402(10415):1835-1847. doi: 10.1016/S0140-6736(23)01796-8. Epub 2023 Oct 20.
PubMed 37871608Li L, Wu PS, Liang XM, Chen K, Zhang GL, Su QB, Huo RR, Xie RW, Huang S, Ma L, Zhong JH. Adjuvant immune checkpoint inhibitors associated with higher recurrence-free survival in postoperative hepatocellular carcinoma (PREVENT): a prospective, multicentric cohort study. J Gastroenterol. 2023 Oct;58(10):1043-1054. doi: 10.1007/s00535-023-02018-2. Epub 2023 Jul 14.
PubMed 37452107
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Immune CheckPoint InhibitoRs Based ThErapy in PostoperatiVe HEpatocellular CarciNoma: a ProspecTive Real-world Study
- ClinicalTrials.gov ID
- NCT05221398
- Acronym / sponsor ID
- PREVENT-1
- Conditions
- Hepatocellular Carcinoma
- Keywords
- immune checkpoint inhibitor, adjuvant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 18 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 3 Feb 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.
Though hepatectomy is one of the curative treatment for patients with hepatocellular carcinoma (HCC), the 5-years recurrence-free survival is lower than 30%. In recent years, several immune checkpoint inhibitors have been approved in advanced HCC. However, no study about the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with HCC after hepatectomy was reported.
Detailed description
Hepatic resection is one of the curative treatment for patients with early stage hepatocellular carcinoma (HCC) or selected intermediate or advanced disease. However, the postoperative 5-years recurrent rate is up to 70%, for whom recurrence is a major cause of death. In recent years, several immune checkpoint inhibitors have been approved in advanced HCC by official guidelines. At the same time, four randomizead controlled trials about adjuvant immune checkpoint inhibitors for postoperative HCC are ongoing. However, no study about the safety and efficacy of adjuvant immune checkpoint inhibitors for such patients in clinical practice was reported. Therefore, the investigators plan to investigate the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with high-risk factor of HCC recurrence after curative hepatectomy in a prospective cohort study with real word clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immune checkpoint inhibitors based adjuvant therapy | – | Drug: Immune Checkpoint Inhibitors Based Adjuvant therapyPatients in this arm will receive immune checkpoint inhibitors based adjuvant therapy. |
| Without adjuvant therapy | – | Other: Active surveillancePatients in this arm will not receive any adjuvant therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatocellular carcinoma who underwent curative hepatectomy. And then, these patients receive adjuvant immune checkpoint inhibitors therapy or active surveillance.
Key inclusion criteria (5 listed)
- Underwent curative hepatectomy;
- Diagnosis of HCC was confirmed by postoperative histopathology;
- Liver function Child-Pugh A or B;
- Performance status score 0 or 1
- With high risk factor of HCC recurrence, such as tumor size ≥ 5 cm, multinodular, macrovascular invasion or microvascular invasion;
Key exclusion criteria (1 listed)
- Receive neoadjuvant immune checkpoint inhibitors 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 |
|---|---|---|
| Immune Checkpoint Inhibitors Based Adjuvant therapyPatients in this group will recieve immune checkpoint inhibitors based adjuvant therapy | Drug | Immune checkpoint inhibitors based adjuvant therapy |
| Active surveillancePatients in this group only receive active surveillance | Other | Without adjuvant therapy |
Primary outcome
Recurrence-free survivial
Time frame: 1 year
Recurrence-free survival is calculated from the date of liver resection to the date of tumor recurrence or death from any cause, whichever occurred first.
1 secondary outcome
Overall survival
Time frame: 1 year
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 7 Oct 2026.
- Background: PubMed 41580093Yopp A, Chen M, Cheng AL, Kaseb A, Kudo M, Lee HC, Cha E, Hack SP, Lian Q, Spahn J, Wu C, Qin S, Chow PK. Updated data from IMbrave050: Adjuvant atezolizumab plus bevacizumab for high-risk hepatocellular carcinoma. J Hepatol. 2026 Jun;84(6):1102-1111. doi: 10.1016/j.jhep.2026.01.006. Epub 2026 Jan 22.
- Background: PubMed 37871608Qin S, Chen M, Cheng AL, Kaseb AO, Kudo M, Lee HC, Yopp AC, Zhou J, Wang L, Wen X, Heo J, Tak WY, Nakamura S, Numata K, Uguen T, Hsiehchen D, Cha E, Hack SP, Lian Q, Ma N, Spahn JH, Wang Y, Wu C, Chow PKH; IMbrave050 investigators. Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Nov 18;402(10415):1835-1847. doi: 10.1016/S0140-6736(23)01796-8. Epub 2023 Oct 20.
- Results publication: PubMed 37452107Li L, Wu PS, Liang XM, Chen K, Zhang GL, Su QB, Huo RR, Xie RW, Huang S, Ma L, Zhong JH. Adjuvant immune checkpoint inhibitors associated with higher recurrence-free survival in postoperative hepatocellular carcinoma (PREVENT): a prospective, multicentric cohort study. J Gastroenterol. 2023 Oct;58(10):1043-1054. doi: 10.1007/s00535-023-02018-2. Epub 2023 Jul 14.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, 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 5 inclusion and 1 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 7 Oct 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.
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 Jian-Hong Zhong, PhD (+86 15296561499, zhongjianhong@gxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survivial (time frame: 1 year). 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 NCT05221398, which also lists 3 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 7 Oct 2026.