Sotorasib in KRAS p.G12C-Mutated Advanced Pancreatic Cancer.
John H Strickler, Hironaga Satake, Thomas J George...
https://pubmed.ncbi.nlm.nih.gov/36546651Actively Recruiting
Led by British Columbia Cancer Agency · Updated on 2026-01-16
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
B
British Columbia Cancer Agency
Lead Sponsor
T
Terry Fox Research Institute
Collaborating Sponsor
Researchers are investigating whether genetic information and proteins from tumors can help guide treatment for people with pancreatic ductal adenocarcinoma (PDAC). The study aims to find out if genetic testing results can be obtained quickly enough to influence treatment decisions and whether these results can predict how tumors respond or resist treatment. This trial is led by the British Columbia Cancer Agency and focuses on different stages of PDAC, including resectable, borderline resectable, and locally advanced cases. Participants will receive standard chemotherapy treatments such as FOLFIRINOX or gemcitabine-based regimens. They will provide samples of tumor tissue, fluid, and blood at various points during the study. Tumor samples are collected during standard surgery or optional biopsies, while fluid samples are taken during a standard laparoscopy procedure. Blood samples will be collected multiple times throughout the trial. The study is non-randomized and includes three groups based on disease stage. Throughout the study, participants will visit the clinic every four weeks for check-ups and tests, and complete questionnaires every 12 weeks. Researchers will monitor the time taken to return comprehensive genomic results, and assess treatment responses using measures like overall response rate, disease control rate, duration of response, progression-free survival, and overall survival. Participants will be followed for up to 72 months to evaluate these outcomes and ensure ongoing safety.
CONDITIONS
Using Tumour DNA and Proteins to Better Understand How Pancreatic Cancer Responds to Treatment
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks from surgery or baseline sample collection
Participants provide tumour tissue and normal tissue samples from biopsy or standard resection surgery prior to starting treatment. Fluid samples are collected from a standard laparoscopy procedure, and blood samples are collected at several timepoints throughout the study.
1 surgery or biopsy visit and multiple blood sample visits
Duration - Until disease progression, withdrawal, or end of study (up to 72 months)
Participants receive standard chemotherapy regimens (FOLFIRINOX or gemcitabine-based) as part of their care.
Regular treatment visits as per standard chemotherapy schedule
Duration - After completion of treatment
Participants may undergo optional tumour and normal tissue biopsy after the last dose of treatment for additional sample collection.
1 optional biopsy visit (in-person)
Total: 1 location
1
BC Cancer
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
D
Daniel J Renouf, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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