Clinical trial · Observational
Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QPOP | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient
- description
- Patient with first-line gastrointestinal cancers and patient with advanced and refractory GI cancers (\>1 line of treatment), or post-progression biopsy)
- interventionNames
- Device: QPOP
Primary outcomes (3)
- measure
- Rates of radiological response
- timeFrame
- 3 years
- description
- complete and partial clinical response, including confidence intervals.
- measure
- Percentage of patients with successful organoid generation for each different tumour type.
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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 criteriaReferences
Publications (2)
- RESULTCancer Genome Atlas Network. Comprehensive molecular characterization of human colon and rectal cancer. Nature. 2012 Jul 18;487(7407):330-7. doi: 10.1038/nature11252. PMID 22810696
- RESULTAACR 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. PMID 28572459