None listed
Conditions
Brief summary
This study will be investigating the safety and tolerability of an implantable device to administer chemotherapy directly to the tumour site for people with confirmed borderline resectable or locally advanced pancreatic cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have biopsy proven pancreatic ductal adenocarcinoma with borderline resectable or locally advanced disease that has not spread to other organs, and you have not had any prior treatment for your cancer. Up to 12 participants who meet the inclusion criteria will be recruited for this study. All participants will undergo a standard diagnostic surgery at which time the trained surgeon will insert the intervention device directly onto the pancreas. The device will then slowly release a chemotherapy drug (paclitaxel) before being biodegraded. There is no need for a second surgery to remove the device. After the device has been inserted, all participants will undergo standard IV chemotherapy as prescribed by a doctor. Participants will be asked to provide weekly blood samples during the first 28 days and will undergo standard of care imaging (CT) to assess for device placement and response to therapy. Participants will be followed weekly for 1 month, at 3 months (for primary endpoints). It is hoped that this research will determine whether an implantable biodegradable device intended to deliver chemotherapy directly to the pancreas is safe and tolerable in patients with pancreatic cancer. If the device is deemed to be safe, this may provide a new method of treatment for future pancreatic cancer patients.
Interventions
PTM-101 is a biodegradable device containing 100mg of paclitaxel. PTM-101 will be placed onto the pancreatic surface overlying the tumor by a surgical oncologist trained in use of PTM-101 using standard laparoscopic surgical equipment as part of a standard of care staging laparoscopy. It is anticipated that placement of PTM-101 will add approximately 20 minutes to the time of the procedure (approximately 30 minutes typically), which will be conducted under general anaesthesia. Documentation of
PTM-101 is a biodegradable device containing 100mg of paclitaxel. PTM-101 will be placed onto the pancreatic surface overlying the tumor by a surgical oncologist trained in use of PTM-101 using standard laparoscopic surgical equipment as part of a standard of care staging laparoscopy. It is anticipated that placement of PTM-101 will add approximately 20 minutes to the time of the procedure (approximately 30 minutes typically), which will be conducted under general anaesthesia. Documentation of PTM-101 placement as part of the diagnostic laparoscopy will be collected. Once in place, PTM-101 will degrade over approximately 10 weeks.
Sponsors
PanTher Therapeutics
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. EUS accessible, biopsy proven PDAC with borderline resectable or locally advanced disease by imaging criteria in accordance with International Consensus Guidelines (S Isaji, 2018) 2. No radiographic evidence of metastatic disease 3. No prior therapy for PDAC 4. ECOG 0 or 1 5. Clinically determined to be able to tolerate neoadjuvant therapy
Exclusion criteria
1. Any other active malignancy 2. Known HIV or active viral hepatitis 3. Active ongoing infection or autoimmune disease which would preclude administration of chemotherapy or surgical intervention 4. Inability to comply with activities and therapeutic interventions as outlined 5. Currently enrolled in another investigational drug or device trial 6. Women who are pregnant or breastfeeding
Outcome results
None listed