VETC is an Effective Marker for Postoperative Adjuvant Immunotherapy

Completed

• Conditions: Recurrence; HCC
• Interventions: Drug: PD-1 monoclonal antibody and lenvatinib

• Registration Number: NCT06253364
• Lead Sponsor: Chen Xiaoping

Brief 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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2023-06-30
• Study Completion: 2024-01-31
• Study First Submitted: 2024-02-03
• Study First Submitted QC: 2024-02-03
• Study First Posted: 2024-02-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-09
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

Inclusion Criteria

• Underwent radical hepatectomy
• No preoperative treatment
• Pathological confirmed HCC
• High-risk recurrent HCC
• Not receiving any adjuvant therapy or receiving adjuvant therapy with PD-1 monotherapy or receiving adjuvant therapy with PD-1 monotherapy in combination with Lenvatinib after surgery

Exclusion Criteria

• Macrovascular invasion
• No available wax blocks
• No complete clinical information

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adjuvant PD-1 plus Lenvatinib group	PD-1 monoclonal antibody and lenvatinib	Adjuvant therapy with PD-1 monoclonal antibody combined with lenvatinib after hepatectomy.
Adjuvant PD-1 group	PD-1 monoclonal antibody and lenvatinib	Adjuvant therapy with PD-1 monoclonal antibody after hepatectomy

Primary Outcome Measures

Name	Time	Method
Disease -free survival	From date of include in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months	Disease-free survival was defined as defined as the time from enrollment to diagnosis of recurrence or death from any cause.

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China