Predictive Value of Minimal Residual Disease for Postoperative Recurrence and Adjuvant PD-1 Inhibitor in HCC

Starting soon · Not applicable

Conditions studied: HCC, Minimal Residual Disease, Recurrence

In brief

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.

Key facts

Study ID

NCT07350824

Run by

Tongji Hospital

People needed

276

Starts

2025-12-31

Expected to finish

2028-12-31

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Child-Pugh liver function score ≤ 7.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Absence of severe organic diseases affecting the heart, lungs, brain, or other major organs.

You may not qualify if…

• History of other malignancies.
• Recurrent HCC.
• Prior systemic therapy for HCC.
• Unable to complete the follow-up and dynamic MRD monitoring.
• Having an immune deficiency disorder.
• Allergic to PD-1 inhibitors or unable to tolerate related treatments.

Where it is running

• Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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