NCT06253364

VETC is an Effective Marker for Postoperative Adjuvant Immunotherapy

A Robust Biomarker of Aggressive HCC and the Response for Adjuvant PD-1 Inhibitors or Combined TKIs Following Liver Resection: Vessels That Encapsulate Tumor Clusters

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 462 (actual)
• 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. However, it is not clear how the surgical prognosis of VETC-positive patients can be improved.

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 is no consensus on postoperative adjuvant therapy for HCC. In recent years, adjuvant immunotherapy (sintilimab) and adjuvant immunotherapy combined with targeted therapy (T+A) have been shown to be effective in improving the surgical prognosis. Therefore, the investigators retrospectively collected three surgical resection cohorts, the surgical resection alone group, the postoperative adjuvant PD-1 monotherapy group, and the postoperative adjuvant PD-1 monotherapy combined with Lenvatinib group, to compare these postoperative adjuvant therapies in a subgroup of VETC patients.

Conditions

• HCC
• Recurrence

Interventions

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

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-06-30
• Completion: 2024-01-31
• First posted: 2024-02-12
• Last updated: 2024-03-13

Locations

1 site across 1 country: China