Overview
Sponsor-declared trial summary
Locally Advanced Pancreatic Cancer
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 limit…
Key facts
- Sponsor
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Dec 2024 → ongoing
- Decision date (initial)
- 2024-12-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519067-17-00
- EudraCT number
- 2018-003925-27
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
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.
Secondary objectives 1
- The secondary objectives of the process are the quantification of the impact of treatment on the patient's quality of life, overall survival and disease-free survival.
Conditions and MedDRA coding
Locally Advanced Pancreatic Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10033609 | Pancreatic carcinoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- 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 13
- Age less than 18 years
- 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
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Increase in the objective response rate of the treated lesion in the treatment arm compared to the control arm
Secondary endpoints 4
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
BLEOPRIM 15 mg polvere per soluzione iniettabile
PRD431183 · Product
- Active substance
- Bleomycin Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 15000 billion organisms billion organisms
- Max total dose
- 15000 billion organisms billion organisms
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DC01 — BLEOMYCIN
- Marketing authorisation
- 022395026
- MA holder
- SANOFI S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CAMPTO 20 mg/mL concentrate for solution for infusion
PRD3700522 · Product
- Active substance
- Irinotecan Hydrochloride Trihydrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 165 mg/m2 milligram(s)/square meter
- Max total dose
- 165 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CE02 — -
- Marketing authorisation
- PL 00057/0627
- MA holder
- PFIZER LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracil 50 mg/ml Solution for Injection or Infusion
PRD1972848 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3200 mg/m2 milligram(s)/sq. meter
- Max total dose
- 3200 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- PL 20075/0078
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Oxaliplatin 5 mg/ml Concentrate for Solution for infusion
PRD10914261 · Product
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 85 mg/m2 milligram(s)/sq. meter
- Max total dose
- 85 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- PL 56284/0009
- MA holder
- EUGIA (UK) LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
LEDERFOLIN 25 mg Polvere per soluzione iniettabile per uso endovenoso
PRD412215 · Product
- Active substance
- Calcium Levofolinate
- Substance synonyms
- Levoleucovorin calcium, CALCIUM (2R)-2-[[4-[[(6S)-2-AMINO-5-FORMYL-4-OXO-1,6,7,8-TETRAHYDROPTERIDIN-6-YL]METHYLAMINO]BENZOYL]AMINO]PENTANEDIOATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 200 mg/m2 milligram(s)/sq. meter
- Max total dose
- 200 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AF04 — CALCIUM LEVOFOLINATE
- Marketing authorisation
- 024659120
- MA holder
- PFIZER ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Sponsor organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Address
- Via Mariano Semmola 52
- City
- Naples
- Postcode
- 80131
- Country
- Italy
Scientific contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Francesco Izzo
Public contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Francesco Izzo
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 90 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2024-12-02 | 2024-12-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocollo di studio versione 1_3 del 6 Nov 2023 red | 1.3 |
| Recruitment arrangements (for publication) | blank document_PDF | 1 |
| Subject information and informed consent form (for publication) | Consenso al trattamento dei dati versione 1_2 del 6 Nov 2023 red | 1.2 |
| Subject information and informed consent form (for publication) | Consenso informato versione 1_1 del 18 Mar 2020 | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | blank document_PDF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | blank document_PDF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | blank document_PDF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | blank document_PDF | 1 |
| Synopsis of the protocol (for publication) | Sinossi versione 1_3 del 6 Nov 2023 red | 1.3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-05 | Italy | Acceptable 2024-11-25
|
2024-12-02 |