Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastrointestinal Cancer
- Sponsor
- National University Hospital, Singapore
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Rates of radiological response
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •There are no specific exclusion criteria if patients meet the inclusion criteria
Outcomes
Primary Outcomes
Rates of radiological response
Time Frame: 3 years
complete and partial clinical response, including confidence intervals.
Percentage of patients with successful organoid generation for each different tumour type.
Time Frame: 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
Time Frame: 3 years
measured by Overall Response Rate for patients with gastric cancer.
Secondary Outcomes
- Haematologic and non-haematologic toxicities(3 years)