RecruitingPhase 4NCT06311929

Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

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


Sponsor

Chen Xiaoping

Enrollment

300 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a personalized (precision) approach to therapy after surgical removal of hepatocellular carcinoma (liver cancer). It focuses specifically on patients whose tumor has a particular blood vessel growth pattern (called VETC) that makes the cancer more likely to return. The goal is to select the right follow-up treatment to reduce recurrence. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with liver cancer (hepatocellular carcinoma) and have not had any prior treatment - Your liver function score (Child-Pugh) is 7 or below - You are in good general health (ECOG 0–1) - Your tumor tissue testing confirms the VETC vascular pattern by special staining (CD34 immunohistochemistry) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active serious infections - You have had gastrointestinal bleeding within the past 4 weeks or are at high risk for it - You have significant absorption problems or chronic severe diarrhea Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-1 monoclonal antibody and lenvatinib

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.

DRUGPD-1 monoclonal antibody

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


Locations(1)

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

Wuhan, Hubei, China

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NCT06311929


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