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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06045975
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • HCC - Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Mar 28, 2024
Status verified
Apr 2026
Primary completion
Sep 27, 2027
Completion
Sep 27, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab/Tremelimumab
    Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting

Primary Outcome Measure

local recurrence-free survival [ Time Frame: 12 months after PA procedure ]

Related Studies