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NCT Number: NCT06311929

Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

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.

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Key information

Conditions

HCC

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Wuhan, Hubei, 430000, China

Location status: Recruiting

Location contact

WanGuang Zhang

CONTACT

[email protected]

+8613886195965

About this study

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 One of our unpublished retrospective studies found that VETC-positive patients receiving PD-1 monoclonal antibody was not effective in improving prognosis.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Non

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.

Other names: Non

Primary outcomes

  1. Disease-free survival

    Time frame: 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 outcomes

  1. Overall survival

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

WanGuang Zhang

CONTACT

[email protected]

+8613886195965

Sponsors and collaborators

Lead sponsor

Chen Xiaoping

Other

Registry information

Official study title

VETC-based Precision Adjuvant Therapy for Postoperative Hepatocellular Carcinoma: a Prospective Multicenter Cohort Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 15, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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