Personalized management approach for pancreatic cancer in Ontario

Province of Ontario Strategy for Personalized Management of Pancreatic Cancer Trial

This study is testing if using genetic information and 3D tumor models can help doctors find better treatment options for people with pancreatic cancer in Ontario.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05927298 on ClinicalTrials.gov

What this trial studies

This observational study aims to improve treatment options for patients with pancreatic ductal adenocarcinoma (PDAC) by analyzing genetic information and creating 3D tumor models from patient samples. Two cohorts are included: patients with upfront resectable PDAC and those with advanced, unresectable, or metastatic PDAC. Tissue samples will undergo whole genome sequencing and RNA sequencing, while blood and stool samples will be collected for further analysis. The goal is to determine if this integrated approach can increase the number of patients receiving precision-matched treatments in Ontario.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with either upfront resectable PDAC or advanced PDAC that is unresectable or metastatic.

Not a fit: Patients with borderline PDAC or those planned for neoadjuvant chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with pancreatic cancer.

How similar studies have performed: Other studies utilizing genetic profiling and patient-derived models have shown promise in improving treatment strategies for various cancers, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients must have either upfront resectable PDAC or advanced (unresectable or metastatic) PDAC (borderline PDAC and those planned for neoadjuvant chemotherapy excluded)
2. Patients with a histological or radiological diagnosis of pancreatic ductal adenocarcinoma (PDAC). For patients awaiting histological confirmation, tissue obtained at study enrolment or can suffice. For those patients who undergo a resection, surgical tissue will be used.
3. For patients enrolling with resectable PDAC (cohort 1) - the definition of resectability will be according to NCCN guidelines and the patient must be planned for a surgery first approach.
4. For patients with advanced PDAC (cohort 2), all stages are eligible including locally advanced unresectable, first-line metastatic, second-line (or beyond) metastatic.
5. In advanced PDAC patients (cohort 2) where a single lesion is to be biopsied, the lesion should be amenable to a core needle biopsy as judged by a staff radiologist. A minimum of 4 to 6 x 18 Gauge (G) good quality tumour cores must be safely obtainable under CT or US guidance.
6. Patients must have a life expectancy of ≥ 6 months
7. ECOG 0-1
8. Patient must be suitable for systemic therapy
9. Patients should have organ function deemed sufficiently adequate to receive systemic therapy

Exclusion Criteria:

1. Certain histologies are excluded: colloid, high grade neuroendocrine;
2. For patients enrolling in cohort 2 - Patients without a tumour lesion amenable to biopsy or with tumour lesions that are not safe for sampling a minimum of 4 to 6 x 18G good quality tumour cores by image guided core needle biopsy as judged by a staff radiologist.
3. Patients who are not fit enough to undergo a tumour biopsy for any reason as judged by the investigator; this includes patients who cannot stop anticoagulation therapy.
4. For cohort 1 - patients receiving neoadjuvant chemotherapy are excluded, (neoadjuvant immunotherapy is permitted)

Where this trial is running

Toronto, Ontario

• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Erica Tsang, MD — University Health Network, Toronto
• Study coordinator: Anna Dodd

Conditions Pancreas Cancer