Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Immune checkpoint inhibitors based adjuvant therapy Patients in this arm will receive immune checkpoint inhibitors based adjuvant therapy. |
Drug: Immune Checkpoint Inhibitors Based Adjuvant therapy
Patients in this group will recieve immune checkpoint inhibitors based adjuvant therapy
|
| Without adjuvant therapy Patients in this arm will not receive any adjuvant therapy. |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Underwent curative hepatectomy;
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Diagnosis of HCC was confirmed by postoperative histopathology;
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Liver function Child-Pugh A or B;
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Performance status score 0 or 1
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jian-Hong Zhong | Nanning | Guangxi | China | 530021 |
Sponsors and Collaborators
- Guangxi Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Xu J, Shen J, Gu S, Zhang Y, Wu L, Wu J, Shao G, Zhang Y, Xu L, Yin T, Liu J, Ren Z, Xiong J, Mao X, Zhang L, Yang J, Li L, Chen X, Wang Z, Gu K, Chen X, Pan Z, Ma K, Zhou X, Yu Z, Li E, Yin G, Zhang X, Wang S, Wang Q. Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A Nonrandomized, Open-label, Phase II Trial. Clin Cancer Res. 2021 Feb 15;27(4):1003-1011. doi: 10.1158/1078-0432.CCR-20-2571. Epub 2020 Oct 21.
- PREVENT