Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma

Study Overview
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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.

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.

Official Title
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Adjuvant Immune CheckPoint InhibitoRs Based ThErapy in PostoperatiVe HEpatocellular CarciNoma: a ProspecTive Real-world Study

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Immune Checkpoint Inhibitors Based Adjuvant therapy


Participation Criteria
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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. Exclusion Criteria: Receive neoadjuvant immune checkpoint inhibitors therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immune checkpoint inhibitors based adjuvant therapy<br>Patients in this arm will receive immune checkpoint inhibitors based adjuvant therapy. | Drug: Immune Checkpoint Inhibitors Based Adjuvant therapy<br>* Patients in this group will recieve immune checkpoint inhibitors based adjuvant therapy<br>|
| Without adjuvant therapy<br>Patients in this arm will not receive any adjuvant therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immune checkpoint inhibitor