Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

Phase 4

Recruiting

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

• Registration Number: NCT06311929
• 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. How to improve the prognosis of this group of patients is an urgent issue to be addressed.

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 are no published studies on how to improve prognosis for this population. One of our unpublished retrospective studies found that VETC-positive patients receiving PD-1 monoclonal antibody was not effective in improving prognosis. However, PD-1 monoclonal antibody in combination with PD-1 monoclonal antibody effectively reduced postoperative recurrence and improved prognosis in VETC-positive patients. Based on our previous retrospective data, this multicenter prospective cohort study was designed to further validate and explore effective therapeutics.

Study Timeline

• Study First Submitted: 2024-03-09
• Study First Submitted QC: 2024-03-09
• Study First Posted: 2024-03-15
• Study Start: 2024-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-05
• Last Update Posted: 2024-05-07
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

1. Pregnant and lactating women.
2. 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.).
3. 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.
4. Active infection.
5. Other significant clinical and laboratory abnormalities that affect the safety evaluation.
6. Inability to follow the study protocol for treatment or follow up as scheduled.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined adjuvant therapy group	PD-1 monoclonal antibody and lenvatinib	Patients in the combined adjuvant therapy group received PD-1 monoclonal antibody with Lenvatinb adjuvant therapy after liver resection.
Monotherapy group	PD-1 monoclonal antibody	Patients in the monotherapy group received PD-1 monotherapy after liver resection.

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	DFS defined as time to recurrence or death after surgery.

Secondary Outcome Measures

Name	Time	Method
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	OS defined as time to death from any cause after surgery.

Trial Locations

Locations (1)

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