Molecular Profiling for Biliary Tract Cancer
(COMPASS-B-MUHC Trial)
Trial Summary
What is the purpose of this trial?
Biliary tract cancer (BTC) accounts for \<1% of all cancers, but remains a highly fatal malignancy. Surgical resection is the only hope for cure, but most patients present with advanced disease when curative-intent surgery is not possible. The therapeutic options for patients with advanced disease are limited, primarily to chemotherapeutic regimens, which are based on empiric evidence without the use of biomarkers. These current treatment strategies have been largely ineffective in controlling the disease, resulting in poor survival outcomes of less than 1 year. An understanding of the molecular characteristics of biliary tract cancer may enable stratification of patients into therapies that target specific molecular alterations with greater efficacies and improved clinical outcomes. This study aims to investigate the feasibility and clinical utility of prospective molecular profiling of advanced biliary tract cancer. The primary endpoint of this study is to demonstrate the feasibility of returning whole genome sequencing results within 8 weeks of tumour biopsy for second-line treatment consideration (n=30 patients). In parallel, tumour whole transcriptome sequencing will be performed to identify actionable molecular alterations (e.g., fusion transcripts). Once the primary endpoint is met, the study will be expanded. Current funding allows expansion to 40 patients in total.
Eligibility Criteria
This trial is for adults with advanced biliary tract cancer that can't be removed by surgery. They must have a measurable tumor, understand and sign consent, have an ECOG status ≤1 (which means they are able to walk and capable of all self-care), expect to live more than 90 days, and have normal organ/marrow function. They should've had gemcitabine-based treatment first without success.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Molecular Profiling
Tumour biopsy is performed for whole genome and transcriptome sequencing to identify actionable molecular alterations
Treatment
Chemo-naive patients receive first-line gemcitabine-based chemotherapy or an investigational drug
Follow-up
Participants are monitored for disease control, progression-free survival, and overall survival
Treatment Details
Interventions
- Tumour and germline molecular profiling
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
Cancer Research Society
Collaborator
Cancer Research Society
Collaborator