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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

Phase 2
Not yet recruiting
Conditions
Locally Advanced Pancreatic Cancer
Registration Number
2024-519067-17-00
Lead Sponsor
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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
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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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, Italy
Gennaro Galizia
Site contact
0815665170
gennaro.galizia@unicampania.it

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