Intra-Tumoral Vascular Growth Patterns is a Robust Indicator of Adjuvant Therapy Following Liver Resection in HCC

NCT06461936 | Active Not Recruiting

• 1 other identifier: PrecisionAT
• Study Type: observational
• Target: 620
• 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; Adjuvant Therapy; Immunotherapy; Recurrence

Outcome Measures

Primary Outcomes (1)

• Disease -free survival

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

  From date of surgery to the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.

Secondary Outcomes (1)

• Overall survival

  From date of surgery to the date of death from any cause, assessed up to 60 months.

Study Arms (3)

Active Surveillance Group（AC）

Patients in AC group received no adjuvant therapy after liver resection.

Adjuvant sintilimab group（AS）

Patients in AS group received adjuvant sintilimab after liver resection.

Drug: Sintilimab

Adjuvant sintilimab plus Lenvatinib group （ASL）

Patients in ASL group received adjuvant sintilimab plus lenvatinib therapy after liver resection.

Drug: Sintilimab; Drug: Lenvatinib

Interventions

Sintilimab DRUG

Patient receives first adjuvant PD-1monoclonal antibody 2-4 weeks postoperatively, 200mg IV over 21 days for 9 cycles.

Adjuvant sintilimab group（AS）; Adjuvant sintilimab plus Lenvatinib group （ASL）

Lenvatinib DRUG

Lenvatinib is initiated orally 2-4 weeks postoperatively for about 6 months.

Adjuvant sintilimab plus Lenvatinib group （ASL）

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

Three cohort cases were retrospectively collected from 4 medical centers according to the study design. Most of the data of AS cohort were obtained from a prospective cohort study of Tongji Hospital.

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
• Evaluable wax block tissue as well as complete clinical information

You may not qualify if:

• Distant metastasis
• No available wax blocks

Sponsors & Collaborators

• Chen Xiaoping: lead

Study Sites (1)

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

Wuhan, Hubei, 430000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Transcriptome, protein and metabolome sequencing were performed on frozen and paraffin-block tissues from selected patients. Paraffin-block tissues were used for spatial transcriptome analysis.

MeSH Terms

Conditions

Recurrence

Interventions

sintilimab; lenvatinib

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: January 1, 2019
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)