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Prospective phase IIb study to evaluate the efficacy of laparoscopic electrochemotherapy in the treatment of locally advanced pancreatic cancer - ECT-LAPC Laparoscopic
EU CTIS ID: 2024-519067-17-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Age less than 18 years
- Contraindications at the assumption of bleomycin (Bleoprim)
- Previous allergic reactions to bleomycin
- Previous cumulative dose of 250 mg/m2 of bleomycin exceeded
- Pregnancy or lactation
- Absolute contraindication to surgery
See the full eligibility criteria
- 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 less than 18 years
- Contraindications at the assumption of bleomycin (Bleoprim)
- Previous allergic reactions to bleomycin
- Previous cumulative dose of 250 mg/m2 of bleomycin exceeded
- Pregnancy or lactation
- Absolute contraindication to surgery
- Visceral, bone or diffuse metastases
- Presence of extrahepatic spread of the disease
- Clinically significant ascites
- Any serious and uncontrolled systemic illness
- Acute lung infection
- Symptoms of poor lung function by clinical examination and Pulmonary function tests (PFT)
- Non correctable severe coagulation disorders
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.