Hepatocellular Carcinoma
Conditions
Keywords
immune checkpoint inhibitor
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.
Interventions
DRUGImmune Checkpoint Inhibitors Based Adjuvant therapy
Patients in this group will recieve immune checkpoint inhibitors based adjuvant therapy
OTHERActive surveillance
Patients in this group only receive active surveillance
Sponsors
Guangxi Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed