2024-519067-17-00RecruitingPhase 2
Prospective phase IIb study to evaluate the efficacy of laparoscopic electrochemotherapy in the treatment of locally advanced pancreatic cancer - ECT-LAPC Laparoscopic
IRCCS Istituto Nazionale Tumori Fondazione Pascale5 sites in 1 country90 target enrollmentStarted: December 2, 2024Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 90
- Locations
- 5
- Primary Endpoint
- Increase in the objective response rate of the treated lesion in the treatment arm compared to the control arm
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion 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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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 Outcomes
- 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
- Assess the toxicity associated with Electrochemotherapy treatment.
- Evaluate the conversion rate of the disease from locally advanced to resectable between the two arms.
Investigators
Francesco Izzo
Scientific
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Study Sites (5)
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