Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers (BTC) for Better Treatment Selection: A Prospective Study (COMPASS B)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy.
研究概览
简要总结
This is a study where fresh tumor tissue and blood samples will be collected from patients with advanced biliary tract cancer who will be undergoing 1st line therapy with gemcitabine or fluorouracil (5-FU) regimens to see how useful it is to look for changes and characteristics in genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour to find characteristics that may be useful in choosing treatments for patients in the future.
详细描述
Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with unresectable or metastatic biliary tract cancer and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a histological or radiological diagnosis of inoperable or metastatic biliary tract cancer (BTC).
- •Patient must have a tumor lesion that is amenable to a core needle biopsy as judged by a staff radiologist.
- •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 enough to safely undergo a tumor biopsy as judged by the investigator.
- •Eastern Cooperative Group (ECOG) performance status ≤ 1 (Karnofsky ≥60%).
- •Life expectancy of greater than 90 days, as judged by the investigator.
- •Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function.
- •Patients must undergo systemic treatment with gemcitabine or 5-FU 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.
排除标准
- •Patients with one or more contraindications to tumor biopsy.
- •Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the advanced setting.
- •Patients who are currently on anti-cancer treatment including chemotherapy.
- •Patients with known brain metastases are excluded from participation in this clinical study.
- •Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
结局指标
主要结局
Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy.
时间窗: 8 Weeks
次要结局
- Disease control rate(4 years)
- Progression-free survival rate(4 years)
- Overall survival rate(4 years)
- Genomic predictors of response to chemotherapy identified(4 years)
- Germline mutations of hereditary risk factors(4 years)
- Potential predictive biomarkers of response to treatment such as BRCA, PALB2 and ATM mutations.(4 years)