NCT04156087CompletedPhase 2
Progression-free Survival After MWA Plus Durvalumab and Tremelimumab for Unresectable Locally Advanced Pancreatic Cancer
Progression-free Survival After Minimally Invasive Surgical Microwave Ablation Plus Durvalumab (MEDI4736) and Tremelimumab for Unresectable Non-metastatic Locally Advanced Pancreatic Cancer: MIMIPAC Trial
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 5 Nov 2019
- Start date
- 9 May 2020
- Primary completion date
- 29 Jan 2024
- Lead sponsor
- Baki Topal
- Diseases
- Pancreatic cancer
- NCT number
- NCT04156087
- EudraCT number
- 2018-002852-34
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 12
- From 9 May 2020 to the primary completion date, 29 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals KU Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.