Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

NCT06311929 | Recruiting Phase 4

• 1 other identifier: Precision AT-01
• Study Type: interventional
• Target: 300
• 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. How to improve the prognosis of this group of patients is an urgent issue to be addressed.

Conditions

HCC

Keywords

HCC; Adjuvant therapy; VETC; PD-1 inhibitor; Lenvatinib

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  DFS defined as time to recurrence or death after surgery.

  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

Secondary Outcomes (1)

• Overall survival

  From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months

Study Arms (2)

Combined adjuvant therapy group

EXPERIMENTAL

Patients in the combined adjuvant therapy group received PD-1 monoclonal antibody with Lenvatinb adjuvant therapy after liver resection.

Drug: PD-1 monoclonal antibody and lenvatinib

Monotherapy group

ACTIVE COMPARATOR

Patients in the monotherapy group received PD-1 monotherapy after liver resection.

Drug: PD-1 monoclonal antibody

Interventions

PD-1 monoclonal antibody and lenvatinib DRUG

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.

Also known as: Non

Combined adjuvant therapy group

PD-1 monoclonal antibody DRUG

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

Also known as: Non

Monotherapy group

Eligibility Criteria

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

You may qualify if:

• Aged 18-75.
• No previous local or systemic treatment for hepatocellular carcinoma.
• Child-Pugh liver function score ≤ 7.
• ECOG PS 0-1.
• No serious organic diseases of the heart, lungs, brain, kidneys, etc.
• Pathologic type is hepatocellular carcinoma.
• Confirmation of the presence of VETC vascular pattern by CD34 immunohistochemical staining.

You may not qualify if:

• Pregnant and lactating women.
• Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).
• A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator.
• Active infection.
• Other significant clinical and laboratory abnormalities that affect the safety evaluation.
• Inability to follow the study protocol for treatment or follow up as scheduled.

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

RECRUITING

MeSH Terms

Interventions

lenvatinib; spartalizumab

Study Officials

• Xiaoping Chen

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WanGuang Zhang

CONTACT

+8613886195965; wgzhang@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 15, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)