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Recruiting Phase 4 NCT06311929

Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

Trial Parameters

Condition HCC
Sponsor Chen Xiaoping
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-04-01
Completion 2027-12-31
Interventions
PD-1 monoclonal antibody and lenvatinibPD-1 monoclonal antibody

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.

Eligibility Criteria

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 (

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