Predictive Value of Minimal Residual Disease for Postoperative Recurrence and Adjuvant PD-1 Inhibitor in HCC
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital
About this trial
Hepatocellular carcinoma (HCC) is a leading global cause of cancer-related mortality. While curative resection is pivotal, high postoperative recurrence rates remain a major challenge. Adjuvant immune checkpoint inhibitors (ICIs) show promise in improving outcomes, but biomarkers to identify patients who will benefit are lacking. Current clinicopathological risk factors for minimal residual disease (MRD) are suboptimal in sensitivity and specificity.
Circulating tumor DNA (ctDNA) analysis, reflecting real-time tumor dynamics, offers a promising approach for MRD detection. This study focuses on the methylation status of GNB4 and Riplet-genes located within HCC-associated CpG islands-using a bespoke bisulfite-conversion and qPCR assay to sensitively detect methylated alleles, thereby enabling MRD monitoring.
To clinically validate this approach, we will conduct a prospective, multicenter cohort study assessing the predictive value of serial \*GNB4/Riplet\* methylation testing for recurrence and adjuvant therapy benefit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years, inclusive, regardless of gender.
Newly diagnosed, treatment-naïve patients with HCC.
Received radical treatments, such as liver resection or microwave ablation.
Combine at least one of the risk factors for tumor recurrence, such as microvascular/macrovascular invasion, poor differentiation, satellite nodules, multiple tumors, and tumor diameter greater than 5 cm.
Disqualifiers
History of other malignancies.
Recurrent HCC.
Prior systemic therapy for HCC.
Unable to complete the follow-up and dynamic MRD monitoring.
Trial design
Design model
Parallel
Treatments tested in this trial
Adjuvant PD-1 inhibitors
DrugThe patients in the postoperative adjuvant treatment cohort received regular PD-1 inhibitor adjuvant therapy (Sintilimab), once every 21 days, for a total of 8 times, and undergoing dynamic MRD testing.
Active monitoring
Other interventionThe patients in the active monitoring cohort only received regular follow-up and MRD testing after the surgery.
Treatment groups
276 Participants
are divided into 2 treatment groupsGroup A: Postoperative active monitoring cohortActive comparator 1 intervention
Group B: Postoperative PD-1 inhibitor adjuvant therapy cohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Disease-free survival(DFS)
DFS is defined as the time from surgery to the first recurrence. The difference in DFS between the two cohorts is compared.
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 60 months.Secondary outcomes
1
Overall survival(OS)
OS is defined as the time from surgery to the date of death.
Time frame
From date of surgery until the date of death from any cause, assessed up to 96 months.Other outcomes
1
Association between dynamic Minimal Residual Disease (MRD) status and Disease-free survival (DFS)
The predictive efficacy of dynamic MRD monitoring for recurrence. MRD will be assessed in peripheral blood samples at specified time points. The association between MRD status (positive/negative) and DFS will be quantified using Cox proportional hazards regression. The primary analysis will evaluate the hazard ratio for recurrence or death in MRD-positive vs. MRD-negative participants.
Time frame
From baseline up to 24 months.Sponsors and contacts
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Source ClinicalTrials.gov
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