NCT05221398

Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 517 (actual)
• Sponsor: Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Immune Checkpoint Inhibitors Based Adjuvant therapy	Patients in this group will recieve immune checkpoint inhibitors based adjuvant therapy
OTHER	Active surveillance	Patients in this group only receive active surveillance

Timeline

• Start date: 2019-03-03
• Primary completion: 2023-01-18
• Completion: 2023-03-17
• First posted: 2022-02-03
• Last updated: 2024-09-25

Locations

1 site across 1 country: China