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Progression-free Survival After MWA Plus Durvalumab and Tremelimumab for Unresectable Locally Advanced Pancreatic Cancer — MIMIPAC  

Pancreatic Cancer Non-resectable Clinical Trial

Official title:
Progression-free Survival After Minimally Invasive Surgical Microwave Ablation Plus Durvalumab (MEDI4736) and Tremelimumab for Unresectable Non-metastatic Locally Advanced Pancreatic Cancer: MIMIPAC Trial

Clinical Trial Summary

This phase-2 monocenter non-randomized prospective clinical trial evaluates the effectiveness of minimally invasive microwave ablation plus immunotherapy for unresectable non-metastatic locally advanced pancreatic cancer.

Clinical Trial Description

Research Hypothesis Does MIS-MWA combined with durvalumab (MEDI4736) plus tremelimumab and gemcitabine prolong progression-free survival in patients with unresectable non-metastatic adenocarcinoma of the pancreas? Investigational Product(s) and Reference Therapy: Combination of Durvalumab (fixed dose of 1500 mg) and Tremelimumab (fixed dose of 75 mg) will be given 2 weeks before surgery. Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab After 4 doses of Durvalumab and Tremelimumab, only Durvalumab 1500mg is provided q4w until disease progression. Systemic gemcitabine will be started 6 weeks after MIS-MWA. Gemcitabine will be given at a dose of 1000 mg /m² body surface, once a week for 3 weeks, followed with a week of rest. Objectives: Primary Objectives: Progression-free survival (PFS) Secondary Objectives: - Safety: clinical and hematological toxicity (NCI CTCAE v. 5.0) of chemotherapy and immunotherapy - Safety: number and type of postoperative complications of the MIS-MWA procedure - Length of hospital stay Tertiary Objectives Overall survival (OS) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04156087
Study type Interventional
Source University Hospital, Gasthuisberg
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 9, 2020
Completion date December 31, 2023
View Details
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