Intra-Arterial Isolation Chemotherapy for Locally Advanced Unresectable Pancreatic Cancer

Phase 1

Withdrawn

• Conditions: ocally Advanced Unresectable Pancreatic Adenocarcinoma; Locally Advanced Unresectable Pancreatic Adenocarcinoma; Cancer - Pancreatic

• Registration Number: ACTRN12614000452695
• Lead Sponsor: Professor Rodney J Lane

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1) Patient age = 18 years;
2) Patient must be competent to give consent for treatment, be informed of the possible risks and benefits of the trial, and provide written informed consent to participate;
3) Patient must be fit to undergo surgery for implantation/explantation of the AVAS;
4) Patient must be fit for repeated general anaesthesia as required by the treatment protocol;
5) Histologically proven adenocarcinoma of the pancreas;
6) Pancreatic adenocarcinoma stage confirmed as locally advanced unresectable by pancreatic protocol computed tomography and staging laparoscopy;
7) World Health Organisation (WHO) / Eastern Cooperative Oncology Group (ECOG) score = 2
8) Adequate bone marrow function;
9) Adequate renal function;
10) Adequate liver function;

Exclusion Criteria

1) Metastatic disease;
2) Previous chemotherapy, radiotherapy, or surgery for pancreatic adenocarcinoma;
3) Evidence of prognostically significant ascites;
4) Evidence of pancreatitis;
5) Patient anatomy incompatible with vascular isolation procedure according to CT-angiography findings;
6) All pancreatic lesions are not measurable (RECIST v1.1) by CT scan during patient screening;
7) Allergy to interventional radiology contrast agents;
8) Allergy or hypersensitivity to chemotherapeutic agents used in study treatment;
9) Patients who are enrolled or intend to participate in another clinical trial for treatment of pancreatic adenocarcinoma concurrent with this study;
10) Significant co-morbidities (i.e. life expectancy = 3 months)
11) Co-morbidities or medical conditions that preclude treatment according to the study protocol without unacceptable risk to patient, or preclude testing according to the study protocol;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response Rate (RR) of tumours in pancreas as assessed via CT scans (RECIST criteria)[4-6 weeks after final infusion procedure.]