- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05221398
Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma
June 11, 2023 updated by: Jian-Hong Zhong, Guangxi Medical University
Adjuvant Immune CheckPoint InhibitoRs Based ThErapy in PostoperatiVe HEpatocellular CarciNoma: a ProspecTive Real-world Study
Though hepatectomy is the best 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.
No study about the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with HCC after hepatectomy was reported.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hepatic resection is the best 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 adjvuant 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.
Study Type
Observational
Enrollment (Actual)
517
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jian-Hong Zhong, PhD
- Phone Number: +86 15296561499
- Email: zhongjianhong@gxmu.edu.cn
Study Locations
-
-
Guangxi
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Nanning, Guangxi, China, 530021
- Jian-Hong Zhong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Patients with hepatocellular carcinoma who underwent curative hepatectomy.
And then, these patients receive adjuvant immune checkpoint inhibitors therapy.
Description
Inclusion Criteria:
- 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; Receive immune checkpoint inhibitors based adjuvant therapy.
Exclusion Criteria:
- Receive neoadjuvant immune checkpoint inhibitors therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Immune checkpoint inhibitors based adjuvant therapy
Patients in this arm will receive immune checkpoint inhibitors based adjuvant therapy.
|
Patients in this group will recieve immune checkpoint inhibitors based adjuvant therapy
|
Without adjuvant therapy
Patients in this arm will not receive any adjuvant therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence-free survivial
Time Frame: 12 months
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 12 months
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.
- Chen K, Wei W, Liu L, Deng ZJ, Li L, Liang XM, Guo PP, Qi LN, Zhang ZM, Gong WF, Huang S, Yuan WP, Ma L, Xiang BD, Li LQ, Zhong JH. Lenvatinib with or without immune checkpoint inhibitors for patients with unresectable hepatocellular carcinoma in real-world clinical practice. Cancer Immunol Immunother. 2022 May;71(5):1063-1074. doi: 10.1007/s00262-021-03060-w. Epub 2021 Sep 24.
- Li L, Liang XM, Chen K, Zhang GL, Huang S, Ma L, Zhong JH. Adjuvant immune checkpoint inhibitors and association with recurrence-free survival in postoperative hepatocellular carcinoma (PREVENT): A prospective cohort study. Journal of Clinical Oncology 2023 41:16_suppl, 4119-4119.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2019
Primary Completion (Actual)
January 18, 2023
Study Completion (Actual)
March 17, 2023
Study Registration Dates
First Submitted
January 14, 2022
First Submitted That Met QC Criteria
January 22, 2022
First Posted (Actual)
February 3, 2022
Study Record Updates
Last Update Posted (Actual)
June 13, 2023
Last Update Submitted That Met QC Criteria
June 11, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
Other Study ID Numbers
- PREVENT-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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