Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-03

Study Completion Date

2023-03-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Immune checkpoint inhibitors based adjuvant therapy

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

Immune Checkpoint Inhibitors Based Adjuvant therapy

Intervention Type DRUG

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.

Active surveillance

Intervention Type OTHER

Patients in this group only receive active surveillance

Interventions

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Immune Checkpoint Inhibitors Based Adjuvant therapy

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

Intervention Type DRUG

Active surveillance

Patients in this group only receive active surveillance

Intervention Type OTHER

Eligibility Criteria

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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.