VETC is an Effective Marker for Postoperative Adjuvant Immunotherapy

NCT06253364 | Completed

• 1 other identifier: Biomarker1
• Study Type: observational
• Target: 462
• Locations: 1 country
• Sites: 1

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.

Conditions

HCC; Recurrence

Outcome Measures

Primary Outcomes (1)

• Disease -free survival

  Disease-free survival was defined as defined as the time from enrollment to diagnosis of recurrence or death from any cause.

  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

Study Arms (3)

Liver resection group

No adjuvant therapy after hepatectomy.

Adjuvant PD-1 group

Adjuvant therapy with PD-1 monoclonal antibody after hepatectomy

Drug: PD-1 monoclonal antibody and lenvatinib

Adjuvant PD-1 plus Lenvatinib group

Adjuvant therapy with PD-1 monoclonal antibody combined with lenvatinib after hepatectomy.

Drug: PD-1 monoclonal antibody and lenvatinib

Interventions

PD-1 monoclonal antibody and lenvatinib DRUG

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.

Adjuvant PD-1 group; Adjuvant PD-1 plus Lenvatinib group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who met the inclusion and exclusion criteria were retrospectively collected for this study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chen Xiaoping: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Recurrence

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 12, 2024
• Study Start: January 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: January 31, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)