Prospective phase IIb study to evaluate the efficacy of laparoscopic electrochemotherapy in the treatment of locally advanced pancreatic cancer - ECT-LAPC Laparoscopic
- Conditions
- Locally Advanced Pancreatic Cancer
- Registration Number
- 2024-519067-17-00
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 90
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase in the objective response rate of the treated lesion in the treatment arm compared to the control arm Increase in the objective response rate of the treated lesion in the treatment arm compared to the control arm
- Secondary Outcome Measures
Name Time Method Evaluate the effect of ECT on disease progression-free time and survival. Evaluate the effect of ECT on disease progression-free time and survival.
Evaluate the impact of ECT on quality of life, with particular attention to its effect on pain Evaluate the impact of ECT on quality of life, with particular attention to its effect on pain
Assess the toxicity associated with Electrochemotherapy treatment. Assess the toxicity associated with Electrochemotherapy treatment.
Evaluate the conversion rate of the disease from locally advanced to resectable between the two arms. Evaluate the conversion rate of the disease from locally advanced to resectable between the two arms.
Trial Locations
- Locations (5)
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
🇮🇹Naples, Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale
🇮🇹Naples, Italy
A. O. U. Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria Gaetano Martino Messina
🇮🇹Messina, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹Genoa, Italy
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli🇮🇹Naples, ItalyGennaro GaliziaSite contact0815665170gennaro.galizia@unicampania.it