Molecular profiling for advanced biliary tract cancers

Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers for Better Treatment Selection: a McGill University Health Centre Study (COMPASS-B-MUHC)

This study is testing if looking at the genes of advanced biliary tract cancer can help doctors find better treatment options for patients whose cancer can't be surgically removed.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Montréal, Quebec)
• Trial ID: NCT04318834 on ClinicalTrials.gov

What this trial studies

This study investigates the molecular characteristics of advanced biliary tract cancer (BTC) to improve treatment strategies. By performing tumor and germline molecular profiling, the research aims to identify specific molecular alterations that could guide more effective therapies. The study focuses on patients with inoperable or metastatic BTC who are undergoing standard treatment. The primary goal is to assess the feasibility of this profiling approach in a clinical setting.

Who should consider this trial

Good fit: Ideal candidates include patients with a histological or radiological diagnosis of inoperable or metastatic biliary tract cancer who can safely undergo a tumor biopsy.

Not a fit: Patients who have contraindications to tumor biopsy or have received prior 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 advanced biliary tract cancer.

How similar studies have performed: Other studies have shown promise in using molecular profiling for cancer treatment, suggesting potential success for this approach in biliary tract cancers.

Eligibility criteria

Inclusion Criteria:

* Patients must have a histological or radiological diagnosis of inoperable or metastatic BTC.
* Patient must have a tumour that is amenable to a core needle biopsy.
* Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
* Patients must be fit to safely undergo a tumour biopsy as judged by the investigator.
* Eastern Cooperative Group (ECOG) performance status ≤ 1.
* Life expectancy of greater than 90 days.
* Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function.
* Patients must undergo systemic treatment with gemcitabine-based regimens as first-line standard systemic palliative treatment with or without other investigational agents within a clinical trial.
* Ability to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patients with one or more contraindications to tumour biopsy.
* Patients who have had any prior chemotherapy or other anti-cancer agent in the advanced stage setting.
* Patients who are currently on anti-cancer treatment.
* Patients with known brain metastases.
* Uncontrolled concurrent illness that would limit compliance with study requirements.
* Any other condition that would contraindicate the patient's participation due to safety concerns or compliance with clinical study procedures.

Where this trial is running

Montréal, Quebec

• McGill University Health Centre — Montréal, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: George Zogopoulos, MD, PhD

Conditions: Biliary Tract Cancer, Biliary tract cancer, Cholangiocarcinoma, Molecular Profiling, Whole Genome Sequencing, Whole Transcriptome Sequencing