Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221398
• Other study ID #: PREVENT-1
• Status: Completed
• Start date: March 3, 2019
• Est. completion date: March 17, 2023

Study information

• Verified date: June 2023
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: March 17, 2023
• Est. primary completion date: January 18, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Immune Checkpoint Inhibitors Based Adjuvant therapy
Patients in this group will recieve immune checkpoint inhibitors based adjuvant therapy

Locations

Country	Name	City	State
China	Jian-Hong Zhong	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Chen K, Wei W, Liu L, Deng ZJ, Li L, Liang XM, Guo PP, Qi LN, Zhang ZM, Gong WF, Huang S, Yuan WP, Ma L, Xiang BD, Li LQ, Zhong JH. Lenvatinib with or without immune checkpoint inhibitors for patients with unresectable hepatocellular carcinoma in real-world clinical practice. Cancer Immunol Immunother. 2022 May;71(5):1063-1074. doi: 10.1007/s00262-021-03060-w. Epub 2021 Sep 24. — View Citation

Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745. — View Citation

Li L, Liang XM, Chen K, Zhang GL, Huang S, Ma L, Zhong JH. Adjuvant immune checkpoint inhibitors and association with recurrence-free survival in postoperative hepatocellular carcinoma (PREVENT): A prospective cohort study. Journal of Clinical Oncology 20

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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