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

NCT06045975 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-24

No results posted yet for this study

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)

Conditions

  • HCC - Hepatocellular Carcinoma

Interventions

DRUG

Durvalumab/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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Perre NAHON, MD-PhD · APHP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2027-09-27
Completion
2028-09-27

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06045975 on ClinicalTrials.gov