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

NCT06045975 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: APHP220729
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.1 Durvalumab 1500 mg/Tremelimumab 300 mg infusion in a neoadjuvant setting
2. 2.percutaneous ablation procedure in a curative attempt at Day 30
3. 3.11 monthly Durvalumab 1500 mg infusions.
4. 4.Classical follow-up during an additional year (every 3 months)

Conditions

HCC - Hepatocellular Carcinoma

Keywords

HCC; Electroporation; immunotherapy; radiofrequency ablation; microwave

Outcome Measures

Primary Outcomes (1)

• local recurrence-free survival

  Local recurrence is defined as the emergence of irregular areas enhanced at arterial phase followed by wash out at portal phase observed next to the ablation zone

  12 months after PA procedure

Secondary Outcomes (9)

• Changes of tumorous and non-tumorous perfusion parameters

  one month of neoadjuvant treatment

• Changes of size of nodules following neoadjuvant course

  one month of neoadjuvant treatment

• Incidences of intra segmental/ extra segmental distant recurrence

  Throughout the study, an average of 30 months

• Overall survival

  12 months after PA procedure

• Overall survival

  12 months after PA procedure

Other Outcomes (7)

• Assessment of tumour architecture and cytology : Histological outcome measures

  From inclusion to PA procedure; assessed up to 30 days

• Assessment of tumour architecture and cytology : Histological outcome measures

  From inclusion to PA procedure; assessed up to 30 days

• Assessment of tumour architecture and cytology :Genomics

  From inclusion to PA procedure; assessed up to 30 days

Study Arms (1)

Durvalumab/Tremelimumab

EXPERIMENTAL

Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting

Drug: Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting

Interventions

Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting DRUG

* 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.

Durvalumab/Tremelimumab

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years of age.
• Histological or radiological diagnosis of HCC
• Uninodular HCC ≥ 2 cm and ≤ 5 cm, no macroscopic vascular invasion
• Multinodular maximum 3 nodules ≤ 3 cm
• Body weight \>30 kg
• Liver function status Child-Pugh Class A
• Eastern Cooperative Oncology Group (ECOG) -World Health Organisation (WHO) performance status of 0 or 1
• Adequate bone marrow, liver and renal function as assessed by the following laboratory tests:
• Total bilirubin ≤ 2 mg/dL
• Serum creatinine ≤ 1.5 x ULN
• Lipase ≤ 2 x ULN
• Prothrombine time-international normalized ratio (PT-INR) \< 2.3 and PTT \< 1.5
• Glomerular Filtration Rate (GFR) ≥ 30 mL/min/1.73 m2
• Life expectancy ≥ 3 months
• Female of childbearing potential (WOCBP) or male or female patients of reproductive potential must employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab and tremelimumab combination therapy.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• AstraZeneca: collaborator

Study Sites (1)

Hospitl Avicenne

Bobigny, 93000, France

Location

Related Publications (21)

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

durvalumab; tremelimumab; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Perre NAHON, MD-PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 21, 2023
• Study Start: March 28, 2024
• Primary Completion (Estimated): September 27, 2027
• Study Completion (Estimated): September 27, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

FR (1)