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

• Conditions: Gastrointestinal Cancer
• Interventions: Device: QPOP

• Registration Number: NCT04611035
• Lead Sponsor: National University Hospital, Singapore

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.

Study Timeline

• Study Start: 2020-01-20
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-11-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Efficacy of second-line therapy	3 years	measured by Overall Response Rate for patients with gastric cancer.
Rates of radiological response	3 years	complete and partial clinical response, including confidence intervals.
Percentage of patients with successful organoid generation for each different tumour type.	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.

Secondary Outcome Measures

Name	Time	Method
Haematologic and non-haematologic toxicities	3 years	Toxicity rating using the NCI CTC v4.03 scale

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore