Adjuvant Immune CheckPoint InhibitoRs Based ThErapy in PostoperatiVe HEpatocellular CarciNoma: a ProspecTive Real-world Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 517
- Locations
- 1
- Primary Endpoint
- Recurrence-free survivial
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Immune checkpoint inhibitors based adjuvant therapy
Patients in this arm will receive immune checkpoint inhibitors based adjuvant therapy.
Intervention: Immune Checkpoint Inhibitors Based Adjuvant therapy (Drug)
Without adjuvant therapy
Patients in this arm will not receive any adjuvant therapy.
Intervention: Active surveillance (Other)
Outcomes
Primary Outcomes
Recurrence-free survivial
Time Frame: 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 Outcomes
- Overall survival(12 months)
Investigators
Jian-Hong Zhong
Guangxi Medical University Cancer Hospital
Guangxi Medical University