Clinical trial NCT04611035: Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)
Official title: Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Cancer
Keywords: Qpop
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 20 patients with gastric cancer, and 80 patients with other GI cancers will be first be recruited.

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.

Eligibility criteria: Inclusion Criteria:

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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

Primary outcomes:
measure: Rates of radiological response
timeFrame: 3 years
measure: Percentage of patients with successful organoid generation for each different tumour type.
timeFrame: 3 years
measure: Efficacy of second-line therapy
timeFrame: 3 years
Secondary outcomes:
measure: Haematologic and non-haematologic toxicities
timeFrame: 3 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Wei Peng Yong
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cancer Genome Atlas Network. Comprehensive molecular characterization of human colon and rectal cancer. Nature. 2012 Jul 18;487(7407):330-7. doi: 10.1038/nature11252.
citation: AACR Project GENIE Consortium. AACR Project GENIE: Powering Precision Medicine through an International Consortium. Cancer Discov. 2017 Aug;7(8):818-831. doi: 10.1158/2159-8290.CD-17-0151. Epub 2017 Jun 1.