Adjuvant Anti-PD-1 Therapy in Resected Hepatocellular Carcinoma

ConditionsHCC Adjuvant Therapy Recurrence Immune Checkpoint Inhibitor

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorTongji Hospital

About this trial

Early hepatocellular carcinoma (HCC) recurrence (driven by residual tumors) and late recurrence (driven by de novo tumors) exhibit distinct biological behaviors, suggesting differential therapeutic vulnerabilities. The beneficiaries of adjuvant PD-1 inhibitors (aPD-1) and their efficacy across these temporally divergent recurrence patterns remains unestablished.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 18 and 75;

achieved complete tumor resection;

histological verification of HCC;

liver function classified as Child-Pugh grade A or B;

Disqualifiers

history of other malignancies or recurrent HCC;

extrahepatic metastasis;

prior treatments for HCC;

ongoing severe postoperative complications;

Trial population

The target population was patients with hepatocellular carcinoma who were undergoing curative surgery as initial treatment and who were receiving active surveillance or adjuvant PD-1 inhibitors postoperatively.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

PD-1 Inhibitors
Drug
Patients in the adjuvant cohort received at least one cycle of PD-1 inhibitors.

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Active surveillance cohort0 interventions

Group B: Adjuvant PD-1 inhibitor cohort1 intervention

Trial outcomes

Primary outcomes

Disease free survival

Time frame

From date of surgery until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 96months.

Secondary outcomes

Overall survival

Time frame

From date of enrollment until the date of death from any cause, assessed up to 96 months.

Locations

This trial has no locations.

Sponsors and contacts

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

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: