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NCT07350824

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

Not yet recruiting NA Last updated 20 January 2026
What this trial tests

NA trial testing Adjuvant PD-1 inhibitors in HCC in 276 participants. Not yet recruiting.

Timeline
31 December 2025
Primary endpoint
31 December 2027
31 December 2028

Quick facts

Lead sponsorTongji Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment276
Start date31 December 2025
Primary completion31 December 2027
Estimated completion31 December 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Tongji Hospital

Who can join

Adults 18 to 75, any sex, with HCC or Minimal Residual Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for HCC

Currently open trials in the same condition.

Other Tongji Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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