NCT06311929

Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

VETC-based Precision Adjuvant Therapy for Postoperative Hepatocellular Carcinoma: a Prospective Multicenter Cohort Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Chen Xiaoping · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. How to improve the prognosis of this group of patients is an urgent issue to be addressed.

Detailed description

Previous studies have identified VETC as a new metastatic pattern independent of EMT that may be associated with immunosuppression as well as poor prognosis. Multiple retrospective studies find higher rates of postoperative recurrence, distant metastasis in VETC-positive patients. How to improve surgical prognosis in VETC-positive patients needs to be explored. There are no published studies on how to improve prognosis for this population. One of our unpublished retrospective studies found that VETC-positive patients receiving PD-1 monoclonal antibody was not effective in improving prognosis. However, PD-1 monoclonal antibody in combination with PD-1 monoclonal antibody effectively reduced postoperative recurrence and improved prognosis in VETC-positive patients. Based on our previous retrospective data, this multicenter prospective cohort study was designed to further validate and explore effective therapeutics.

Conditions

• HCC

Interventions

Type	Name	Description
DRUG	PD-1 monoclonal antibody and lenvatinib	Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 9 cycles; lenvatinib is initiated orally 2-4 weeks postoperatively for 6 months.
DRUG	PD-1 monoclonal antibody	Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200mg IV over 21 days for 9 cycles.

Timeline

• Start date: 2024-04-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2024-03-15
• Last updated: 2024-05-07

Locations

1 site across 1 country: China