Health TrialsbyHealthPanel

Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorGuangxi Medical University

About this trial

Though hepatectomy is one of the curative 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. However, no study about the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with HCC after hepatectomy was reported.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Underwent curative hepatectomy;

Diagnosis of HCC was confirmed by postoperative histopathology;

Liver function Child-Pugh A or B;

Performance status score 0 or 1

Disqualifiers

Receive neoadjuvant immune checkpoint inhibitors therapy.

Trial population

Patients with hepatocellular carcinoma who underwent curative hepatectomy. And then, these patients receive adjuvant immune checkpoint inhibitors therapy or active surveillance.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Immune Checkpoint Inhibitors Based Adjuvant therapy

    Drug

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

  • Active surveillance

    Other intervention

    Patients in this group only receive active surveillance

Treatment groups

10,000 Participants
are divided into 2 treatment groups
Group A: Immune checkpoint inhibitors based adjuvant therapy1 intervention
Group B: Without adjuvant therapy1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1 year

Other outcomes

1

Recurrence-free survival

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.

Time frame
3 years
2

Recurrence-free survival

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.

Time frame
5 years
3

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.

Time frame
3 years
4

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.

Time frame
5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangxi Medical University

Lead sponsor

Source ClinicalTrials.gov
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