2024-519067-17-00CompletedPhase 2
Prospective phase IIb study to evaluate the efficacy of laparoscopic electrochemotherapy in the treatment of locally advanced pancreatic cancer - ECT-LAPC Laparoscopic
Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Dec 2024
Brief summary (registry, in English)
The aim of the study is to evaluate the efficacy of electrochemotherapy followed by conventional systemic treatment compared to the only systemic treatment in LAPC in terms of objective response. The use of ECT and IRE, in deep cancer e.g. liver and pancreas, currently requires a laparotomy surgical approach and limits its applicability due to the risks associated with open surgery. In our study a new generation of electrodes suitable to treat tumor nodules with ECT with a minimally invasive approach, i.e. laparoscopic surgery, will be used.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 5 Nov 2024
- Start date
- 2 Dec 2024
- Lead sponsor
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Diseases
- Pancreatic cancer
- EU CT number
- 2024-519067-17-00
- EudraCT number
- 2018-003925-27
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 90
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous allergic reactions to bleomycin
- Previous cumulative dose of 250 mg/m2 of bleomycin exceeded
- Absolute contraindication to surgery
Other illness
- Presence of extrahepatic spread of the disease
- Any serious and uncontrolled systemic illness
- Acute lung infection
- Non correctable severe coagulation disorders
Age
- Age less than 18 years
Other
- Contraindications at the assumption of bleomycin (Bleoprim)
- Pregnancy or lactation
- Visceral, bone or diffuse metastases
- Clinically significant ascites
- Symptoms of poor lung function by clinical examination and Pulmonary function tests (PFT)
Who the study is looking for
- Age≥ 18 years
- Good mental health conditions
- Ability to sign a specific informed consent in order to be enrolled to the study.
- Life expectancy in line with the follow-up indicated by the study
- Diagnosis of exocrine pancreatic cancer with histological confirmation
- Preoperative Staging of locally advanced pancreatic cancer disease: stage III
- The subject is not eligible for the "gold-standard" treatment of surgical pancreatectomy and is eligible for a conventional systemic treatment (FOLFOXIRI)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| A. O. U. Policlinico Sant'Orsola Malpighi | Bologna | Italy | Completed |
| IRCCS Ospedale Policlinico San Martino | Genoa | Italy | Completed |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina | Messina | Italy | Completed |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli | Naples | Italy | Completed |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale | Naples | Italy | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.