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Recruiting Phase 4 NCT06311942

Triple vs. Dual Adjuvant Therapy Following Liver Resection for HCC.

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
HAIC plus PD-1 inhibitors plus lenvatinibPD-1 inhibitors plus lenvatinib

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. What can be done to improve the surgical prognosis of this group of patients needs to be continuously explored.

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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