Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)

National University Health System (NUHS)

Status: Unknown

Conditions: Gastrointestinal Cancer

Treatments: Device: QPOP

Study type: Observational

Funder types: Other

Identifiers

NCT04611035

2019/00924

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients may be included in the study only if they meet the following criteria:

1. 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

2. Chemo-refractory patients with GI cancers deemed by investigator to be fit for clinical trial

3. Age ≥ 21 years

4. ECOG PS 0-1

5. At least 1 tumour lesion amenable to fresh biopsy

6. At least 1 measurable tumour lesion based on RECIST v 1.1 criteria

7. Estimated life expectancy of at least 24 weeks

8. Adequate organ function , including:

   1. Pre-biopsy

      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

   2. 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

      • Hepatic:

        • Bilirubin ≤ 1.5 x upper limit of normal (ULN),
        • ALT or AST ≤ 2.5x ULN, (or ≤ 5 X with liver metastases)

      • Renal:

        • Creatinine ≤ 1.5x ULN

9. Signed informed consent from patient or legal representative

10. Able to comply with study-related procedures.

11. Recovery from prior toxicity to G1, excluding alopecia.

Exclusion criteria

• There are no specific exclusion criteria if patients meet the inclusion criteria

Trial design

100 participants in 1 patient group

Patient

Description:

Patient with first-line gastrointestinal cancers and patient with advanced and refractory GI cancers (\>1 line of treatment), or post-progression biopsy)

Treatment:

Device: QPOP