Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rates of radiological response
研究概览
简要总结
This is a multi-cohort proof of concept study involving patients with metastatic gastrointestinal cancers. In the first cohort of treatment-naïve patients, the investigators intend to create cancer organoids for 100 subjects. Then, the investigators intend to evaluate ex-vivo prediction of treatment outcomes using QPOP (see section 4.0 for detailed sample size calculation).
Patients enrolled on study will undergo a fresh biopsy of tumour lesion to obtain cells that will be used to generate patient-derived tumour organoids. These patients will go on to receive standard of care first-line chemotherapy +/- targeted therapy. Organoids will then be subjected to up to a 14-drug panel screening. The drugs in the respective drug panel have been shown to have activity in the respective cancers and would be used in the standard-of-care setting by treating physicians.
详细描述
Hypothesis
Ex-vivo sensitivity testing on patient derived tumour organoids using QPOP can identify drug combinations which may have clinical efficacy against metastatic gastrointestinal cancer.
Specific aim 1: To grow patients' gastrointestinal tumour-derived organoids.
Specific aim 2: To perform ex-vivo drug sensitivity testing on patient derived tumour organoids using QPOP for metastatic gastrointestinal cancers.
Specific aim 3: Asses the efficacy of phenotype directed therapy using QPOP to assign treatment after progression of standard of chemo for gastric cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients may be included in the study only if they meet the following criteria:
- •Treatment naïve patient with gastrointestinal cancers (i.e. oesophageal, gastro-oesophgeal, gastric, small bowel, colorectal, hepatocellular, pancreatic and biliary tract) fit and planned for first line treatment, OR
- •Chemo-refractory patients with GI cancers deemed by investigator to be fit for clinical trial
- •Age ≥ 21 years
- •ECOG PS 0-1
- •At least 1 tumour lesion amenable to fresh biopsy
- •At least 1 measurable tumour lesion based on RECIST v 1.1 criteria
- •Estimated life expectancy of at least 24 weeks
- •Adequate organ function , including:
- •o Bone marrow:
- •Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L
- •Platelets ≥ 100 x 109/L
- •Pro-Thrombin within ULN
- •Hemoglobin ≥ 8 x 109/L
- •Pre-treatment
- •Bone marrow:
- •Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L
- •Platelets ≥ 100 x 109/L
- •Hemoglobin ≥ 8 x 109/L
- •Bilirubin ≤ 1.5 x upper limit of normal (ULN),
- •ALT or AST ≤ 2.5x ULN, (or ≤ 5 X with liver metastases)
- •Creatinine ≤ 1.5x ULN
- •Signed informed consent from patient or legal representative
- •Able to comply with study-related procedures.
- •Recovery from prior toxicity to G1, excluding alopecia.
排除标准
- •There are no specific exclusion criteria if patients meet the inclusion criteria
结局指标
主要结局
Rates of radiological response
时间窗: 3 years
complete and partial clinical response, including confidence intervals.
Percentage of patients with successful organoid generation for each different tumour type.
时间窗: 3 years
Patients enrolled on study will undergo a fresh biopsy of tumour lesion to obtain cells that will be used to generate patient-derived tumour organoids.
Efficacy of second-line therapy
时间窗: 3 years
measured by Overall Response Rate for patients with gastric cancer.
次要结局
- Haematologic and non-haematologic toxicities(3 years)