Using Tumour DNA and Proteins to Better Understand How Pancreatic Cancer Responds to Treatment

Not Applicable

Not yet recruiting

• Conditions: Borderline Resectable Pancreatic Ductal Adenocarcinoma; Locally Advanced Pancreatic Ductal Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Ductal Adenocarcinoma
• Interventions: Genetic: Genetic testing; Procedure: Optional biopsy

• Registration Number: NCT06574620
• Lead Sponsor: British Columbia Cancer Agency

Brief Summary

The goal of this study is to learn if the genetic information and proteins from tumours can help treat pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are:

* Is it feasible to obtain genetic test results within a timeframe that can help inform treatment decisions for individuals with PDAC?

* Can the genetic test results provide information about how a tumour will respond to or resist treatment?

Participants will:

* Receive standard chemotherapy to treat their cancer.

* Provide samples of their blood, tissue, and fluid for genetic testing.

* Visit the clinic every 4 weeks for check-ups and tests.

* Complete questionnaires every 12 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Study Start: 2025-04
• Primary Completion: 2028-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Borderline Resectable Cohort	Optional biopsy	Participants with borderline resectable PDAC. Participants will provide tumour, fluid, and blood samples for genetic testing and other analyses. Tumour samples will be collected from standard resection surgery and optional biopsies. Fluid samples will be collected from a standard laparoscopy procedure. Blood samples will be collected at several timepoints throughout the study. Participants will receive standard chemotherapy (FOLFIRINOX or gemcitabine-based) regimens.
Resectable Cohort	Genetic testing	Participants with resectable PDAC. Participants will provide tumour, fluid, and blood samples for genetic testing and other analyses. Tumour samples will be collected from standard resection surgery and optional biopsies. Fluid samples will be collected from a standard laparoscopy procedure. Blood samples will be collected at several timepoints throughout the study. Participants will receive standard chemotherapy (folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) or gemcitabine-based) regimens.
Resectable Cohort	Optional biopsy	Participants with resectable PDAC. Participants will provide tumour, fluid, and blood samples for genetic testing and other analyses. Tumour samples will be collected from standard resection surgery and optional biopsies. Fluid samples will be collected from a standard laparoscopy procedure. Blood samples will be collected at several timepoints throughout the study. Participants will receive standard chemotherapy (folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) or gemcitabine-based) regimens.
Locally Advanced Cohort	Genetic testing	Participants with locally advanced PDAC. Participants will provide fluid and blood samples for genetic testing and other analyses. Fluid samples will be collected from a standard laparoscopy procedure. Blood samples will be collected at several timepoints throughout the study. Tumour samples may also be collected, if participants agree to optional biopsies. Participants will receive standard chemotherapy (FOLFIRINOX or gemcitabine-based) regimens.
Borderline Resectable Cohort	Genetic testing	Participants with borderline resectable PDAC. Participants will provide tumour, fluid, and blood samples for genetic testing and other analyses. Tumour samples will be collected from standard resection surgery and optional biopsies. Fluid samples will be collected from a standard laparoscopy procedure. Blood samples will be collected at several timepoints throughout the study. Participants will receive standard chemotherapy (FOLFIRINOX or gemcitabine-based) regimens.
Locally Advanced Cohort	Optional biopsy	Participants with locally advanced PDAC. Participants will provide fluid and blood samples for genetic testing and other analyses. Fluid samples will be collected from a standard laparoscopy procedure. Blood samples will be collected at several timepoints throughout the study. Tumour samples may also be collected, if participants agree to optional biopsies. Participants will receive standard chemotherapy (FOLFIRINOX or gemcitabine-based) regimens.

Primary Outcome Measures

Name	Time	Method
Frequency of comprehensive genomic results returned within 8 weeks of sample collection.	From the date of resection surgery or baseline ctDNA collection until genomic results are available (typically 8 weeks).	The percentage of participants with comprehensive genomic results for their baseline tumour tissue and/or circulating tumour deoxyribonucleic acid (ctDNA) within 8 weeks of their collection.

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR) in each study arm, as defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1	From the date of the baseline scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.	The proportion of participants in each study arm who have a complete response (CR) or partial response (PR) to treatment, as defined by RECIST 1.1.
Progression-free survival (PFS) in each study arm from the initiation of chemotherapy	From the date of first dose of chemotherapy until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.	The number of days from the first dose of chemotherapy until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm.
Disease control rate in each study arm, as defined by RECIST 1.1	From the date of the baseline scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.	The proportion of participants in each study arm who have a complete response (CR), partial response (PR), or stable disease (SD) to treatment, as defined by RECIST 1.1.
Duration of response (DoR) in each study arm, as defined by RECIST 1.1	From the first date of CR or PR until the first date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.	The number of days between the first date of complete response (CR) or partial response (PR) and the earliest date of disease recurrence/progression or death due to any cause.
Overall survival (OS) in each study arm from the initiation of chemotherapy	From the date of first dose of chemotherapy until the date of death or end of study, whichever comes first, assessed up to 72 months.]	The number of days from the initiation of chemotherapy that participants survive in each study arm.

Trial Locations

Locations (1)

BC Cancer; 🇨🇦 Vancouver, British Columbia, Canada