Durvalumab and Tremelimumab with microwave tumor ablation for unresectable locally advanced pancreatic cancer.

Phase 1

• Conditions: nresectable Locally Advanced Non Metastatic Pancreatic Cancer; MedDRA version: 21.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002852-34-BE
• Lead Sponsor: ZLeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-23
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified