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
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