RecruitingPhase 2NCT06045975

Durvalumab/Tremelimumab in Neoadjuvant and Adjuvant Setting in Patients With HCC Treated by by Percutaneous Ablation Procedure

Durvalumab/Tremelimumab in Neoadjuvant and Adjuvant Setting in Patients With HCC Treated by by Percutaneous Ablation Procedure in Curative Intent: French Multicenter Phase 2 Therapeutic

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

30 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

HCC - Hepatocellular Carcinoma

Summary

This project is a Phase 2 trial testing the safety and efficacy of treatment with Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting in patients with BCLC A HCC treated by by percutaneous ablation (PA) procedure in a curative intent. DUMELEP is a Multicentre, Phase 2 trial Eligible patients will receive consecutively: 1. 1 Durvalumab 1500 mg/Tremelimumab 300 mg infusion in a neoadjuvant setting 2. percutaneous ablation procedure in a curative attempt at Day 30 3. 11 monthly Durvalumab 1500 mg infusions. 4. Classical follow-up during an additional year (every 3 months)

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests two immunotherapy drugs — durvalumab and tremelimumab — given before and after surgery for a specific type of liver cancer (hepatocellular carcinoma). Using immunotherapy both before surgery (to shrink the tumor) and after (to prevent recurrence) may lead to better long-term outcomes. **You may be eligible if...** - You are 18 or older - You have been diagnosed with liver cancer that is eligible for surgical removal - Your liver function is adequate for both surgery and immunotherapy - You have not previously received immunotherapy for this cancer **You may NOT be eligible if...** - Your tumor is too advanced for surgery - You have autoimmune diseases that could be worsened by immunotherapy - You have active serious infections including hepatitis - You are pregnant or breastfeeding 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

DRUGDurvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting

* Durvalumab 1500 mg/Tremelimumab 300 mg infusion in a neoadjuvant setting followed by PA procedure at Day 30+/-7 days * 11 monthly Durvalumab 1500 mg infusions.

Locations(1)

Hospitl Avicenne

Bobigny, France

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NCT06045975

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