Tumor DNA and protein testing to understand pancreatic cancer treatment response

Accelerating the Actionability of Treatment in Resected and Locally Advanced Pancreatic Cancer

This trial will test whether measuring tumor DNA and proteins from people with resectable or locally advanced pancreatic ductal adenocarcinoma can be done quickly enough and provide information about how their cancer responds to standard chemotherapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: British Columbia Cancer Agency (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT06574620 on ClinicalTrials.gov

What this trial studies

This interventional study collects tumor tissue, fluid, and blood from adults with resectable, borderline resectable, or locally advanced pancreatic ductal adenocarcinoma who are enrolled in the Personalized Oncogenomics (POG) Program at BC Cancer. Participants receive standard chemotherapy and may undergo optional biopsy or tissue collection during laparoscopy, with samples analyzed for tumor DNA and protein markers. The study measures whether genomic and proteomic results can be returned in a timeframe that could inform treatment decisions and whether those results predict response or resistance to therapy. Clinic visits occur every four weeks and participants complete questionnaires every 12 weeks.

Who should consider this trial

Good fit: Adults (18+) with resectable, borderline resectable, or locally advanced PDAC who are enrolled in BC Cancer's POG program and are medically fit for laparoscopy or surgery are the intended participants.

Not a fit: Patients with metastatic disease, those not enrolled in the POG program, or those who are not medically fit for biopsy or surgery are unlikely to be eligible or to benefit from this approach.

Why it matters

Potential benefit: If successful, doctors could use tumor genetic and protein information to tailor or change treatments more quickly, potentially improving response and outcomes.

How similar studies have performed: Precision oncology programs using tumor genomics and proteomics have shown promise in other cancers, but evidence of clear clinical benefit specifically in pancreatic ductal adenocarcinoma remains limited, making this approach partly novel for PDAC.

Eligibility criteria

Inclusion Criteria:

Participants must meet all of the following criteria prior to Pre-Baseline registration:

1. Age 18 years or older.
2. Histological or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC.
3. Medically fit and planned to undergo laparoscopic procedure as part of standard of care.
4. Able to give informed consent for the study-related procedures performed during laparoscopy.

Participants must meet all of the following criteria to be eligible for enrollment in the Main Study:

1. Age 18 years or older.
2. Enrolled in the Personalized Oncogenomics (POG) Program at BC Cancer.
3. Histological and/or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC. Participants without a histological diagnosis of PDAC must undergo confirmatory histological diagnosis prior to treatment start date.
4. Medically fit to undergo surgical resection of the primary lesion(s) as judged by the investigator (Resectable and Borderline Resectable Cohorts only).
5. Planned for adjuvant (Resectable and Borderline Resectable Cohorts) or first-line (Locally Advanced Cohort) therapy with FOLFIRINOX or a gemcitabine-based regimen, either as part of routine care or in combination with an investigational agent(s) within another clinical trial. Participants may have received pre-operative therapy.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
7. Adequate organ function as defined by the following laboratory results obtained within 28 days prior to enrollment date:

   1. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L.
   2. Hemoglobin ≥ 9 g/dL.
   3. Platelets ≥ 75 x 10\^9/L.
   4. Prothrombin time test and international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 x Upper Limit of Normal (ULN).
   5. Total bilirubin ≤ 1.5 x ULN. Isolated bilirubin \> 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%.
   6. Aspartate aminotransferase (AST) and alanine aminotransferase (AST) ≤ 1.5 x ULN. If liver metastases are present, AST and ALT ≤ 5 x ULN is permitted.
   7. Albumin ≥ 25 g/L.
   8. One of the following:

      * Creatinine ≤ 1.5 x ULN.
      * Calculated creatinine clearance (as calculated by Cockcroft-Gault formula) ≥ 40 mL/min.
      * 24-hour urine creatinine clearance ≥ 40 mL/min.
8. Life expectancy greater than 90 days as judged by the investigator.
9. Able to give informed consent for the study procedures defined in this protocol.
10. Measurable disease by RECIST 1.1. For those in the Resectable and Borderline Resectable Cohorts, measurable disease must be present prior to resection surgery.

Exclusion Criteria:

1. Presence of distant or lymph node metastases. Individuals with metastatic PDAC are not eligible.
2. Currently receiving adjuvant (Resectable and Borderline Resectable Cohorts) or systemic (Locally Advanced Cohort) anti-cancer therapy (chemotherapy or any other anti-cancer agent) with one exception: pre-operative therapy is permitted.
3. Not fit for chemotherapy as judged by the investigator.
4. Presence of brain metastases.
5. Positive pregnancy test.
6. Unable to comply with the study assessments and procedures defined in this protocol.
7. Individuals who are otherwise judged by the investigator to be unfit to proceed with this protocol.

Where this trial is running

Vancouver, British Columbia

• BC Cancer — Vancouver, British Columbia, Canada (RECRUITING)

Study contacts

• Principal investigator: Daniel J Renouf, MD — BC Cancer
• Study coordinator: Daniel J Renouf, MD

Conditions: Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma