Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT04318834
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04318834
Study Brief:
Protocol Section:
NCT04318834