Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Immune Checkpoint Inhibitors Based Adjuvant therapy; Other: Active surveillance

• Registration Number: NCT05221398
• Lead Sponsor: Guangxi Medical University

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.

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 Timeline

• Study Start: 2019-03-03
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-22
• Study First Posted: 2022-02-03
• Primary Completion: 2023-01-18
• Study Completion: 2023-03-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 517

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immune checkpoint inhibitors based adjuvant therapy	Immune Checkpoint Inhibitors Based Adjuvant therapy	Patients in this arm will receive immune checkpoint inhibitors based adjuvant therapy.
Without adjuvant therapy	Active surveillance	Patients in this arm will not receive any adjuvant therapy.

Primary Outcome Measures

Name	Time	Method
Recurrence-free survivial	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival	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.

Trial Locations

Locations (1)

Jian-Hong Zhong; 🇨🇳 Nanning, Guangxi, China