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OpenTrials
Completed

NCT Number: NCT05221398

Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jian-Hong Zhong

Nanning, Guangxi, 530021, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immune Checkpoint Inhibitors Based Adjuvant therapy

Drug

Patients in this group will recieve immune checkpoint inhibitors based adjuvant therapy

Active Surveillance

Other

Patients in this group only receive active surveillance

Primary outcomes

  1. 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

  1. Overall survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Guangxi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2022
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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