Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma

Guangxi Medical University

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Other: Active surveillance; Drug: Immune Checkpoint Inhibitors Based Adjuvant therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05221398

PREVENT-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 517 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

517 participants in 2 patient groups

Immune checkpoint inhibitors based adjuvant therapy

Description:

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

Treatment:

Drug: Immune Checkpoint Inhibitors Based Adjuvant therapy

Without adjuvant therapy

Description:

Patients in this arm will not receive any adjuvant therapy.

Treatment:

Other: Active surveillance