Prospective phase IIb study to evaluate the efficacy of laparoscopic electrochemotherapy in the treatment of locally advanced pancreatic cancer

Phase 1

• Conditions: locally advanced pancreatic carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003925-27-IT
• Lead Sponsor: ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-17
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

a) Age> 18 years
b) Good mental health conditions
c) Ability to sign a specific informed consent in order to be admitted to the study.
d) Life expectancy in line with the follow-up indicated by the study
e) Diagnosis of exocrine pancreatic cancer with histological confirmation
f) Preoperative Staging of locally advanced pancreatic cancer disease: stage III
g) The subject is not eligible for the gold-standard treatment of surgical pancreasectomy and is eligible for a conventional systemic treatment (FOLFOXIRI)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

a) Age less than 18 years
b) Absolute contraindication to surgery
c) Visceral, bone or diffuse metastases
d) Presence of extrahepatic spread of the disease
e) Infection and / or heart failure and / or hepatic failure and / or other serious systemic diseases
f) Clinically significant ascites
g) Any serious and uncontrolled systemic illness
h) Acute pulmonary infection
i) Symptoms of poor lung function
j) Severe coagulation disorders that can not be corrected
k) Previous allergic reactions to bleomycin
l) The cumulative dose of bleomycin of 250 mg / m2 was exceeded
m) Chronic renal dysfunction (creatinine> 150 µmol / L should be considered a lower administered dose of bleomycin)
n) Pregnancy or breastfeeding **

** Pregnancy has been established prior to enrollment by beta-HCG assay on urine (pregnancy test or urinary beta-HCG) or blood (plasma beta-HCG).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified