NCT05221398

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
517

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2023

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

3.9 years

First QC Date

January 14, 2022

Last Update Submit

September 23, 2024

Conditions

Hepatocellular Carcinoma

Keywords

immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • Overall survival

    12 months

Study Arms (2)

Immune checkpoint inhibitors based adjuvant therapy

Patients in this arm will receive immune checkpoint inhibitors based adjuvant therapy.

Drug: Immune Checkpoint Inhibitors Based Adjuvant therapy

Without adjuvant therapy

Patients in this arm will not receive any adjuvant therapy.

Other: Active surveillance

Interventions

Immune Checkpoint Inhibitors Based Adjuvant therapyDRUG

Patients in this group will recieve immune checkpoint inhibitors based adjuvant therapy

Immune checkpoint inhibitors based adjuvant therapy
Active surveillanceOTHER

Patients in this group only receive active surveillance

Without adjuvant therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with hepatocellular carcinoma who underwent curative hepatectomy. And then, these patients receive adjuvant immune checkpoint inhibitors therapy.

You may qualify if:

  • 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.

You may not qualify if:

  • Receive neoadjuvant immune checkpoint inhibitors therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jian-Hong Zhong

Nanning, Guangxi, 530021, China

Location

Related Publications (3)

  • 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.

    PMID: 32402160BACKGROUND

  • 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.

    PMID: 34559308BACKGROUND

  • Li 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.

    PMID: 37452107BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Guangxi Medical University Cancer Hospital

Study Record Dates

First Submitted

January 14, 2022

First Posted

February 3, 2022

Study Start

March 3, 2019

Primary Completion

January 18, 2023

Study Completion

March 17, 2023

Last Updated

September 25, 2024

Record last verified: 2024-09

Locations

CN(1)