Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Clinical summary
Summary
PTM-101 is a biodegradable device containing 100mg of paclitaxel. PTM-101 will be placed onto the pancreatic surface overlying the tumour via a laparoscopy. PTM-101 will degrade over approximately 10 weeks.
Conditions
This trial is treating people with pancreatic ductal adenocarcinoma
Eligibility
Inclusion
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
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
Inclusion
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
PanTher Therapeutics and Avania Clinical
Scientific Title
A Phase I Study of PTM-101 as Neoadjuvant Therapy for Borderline Resectable or Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
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