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

NCT04156087

CompletedPhase 2

Sponsor: Baki Topal

Conditions: Pancreatic Cancer Non-resectable

Interventions: Durvalumab 50 MG/ML, Tremelimumab, Gemcitabine, Minimally Invasive Surgical Microwave Ablation (MIS-MWA)

Countries: Belgium

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients with unresectable non-metastatic Locally Advanced Pancreatic Cancer (LAPC) defined according to NCCN guidelines Version 2.2017
* Histologically proven adenocarcinoma of the pancreas located in the head, body or tail
* LAPC tumor greatest diameter maximum 5 cm
* Male or female, age 18 years and older, ECOG PS 0-1
* Life expectancy of at least 12 weeks
* Only patients who did not receive chemotherapy for their PC are allowed
* Patients without distant organ metastases on conventional diagnostic imaging
* Pre-operative biliary drainage for obstructive jaundice is allowed, but the type of biliary stent is standardized in all jaundiced patients
* Patients fit for MIS-MWA
* Able to receive Durvalumab and Tremelimumab.
* Patients with good liver and renal function and with good hematology
* Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.
* Written informed consent (+ optional for TR) must be given according to ICH/GCP and national/European regulations

Exclusion Criteria:

* Pregnancy
* Metastatic PC on conventional diagnostic imaging or staging laparoscopy
* LAPC tumor greatest diameter is larger than 5 cm
* Borderline or resectable PC defined according to the NCCN guidelines version 2.2017
* Systemic chemo(radio)therapy is not allowed before MIS-MWA
* Major surgical procedure within 28 days prior to the first dose of investigational products
* Classic contraindications for PDL and CTLA antibodies

Locations (1)

Leuven, Vlaams-Brabant, Belgium