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

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611035
• Other study ID #: 2019/00924
• Status: Recruiting
• Start date: January 20, 2020
• Est. completion date: January 2023

Study information

• Verified date: April 2022
• Source: National University Hospital, Singapore
• Contact: Wei Peng Yong
• Phone: 6779 5555
• Email: Wei_Peng_Yong[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Device:
• QPOP
QPOP will then be applied to establish the most efficacious drug combination for the specific organoid. Additional drugs other than those listed above may be screened depending on availability of cancer organoids. When patients progress after first-line treatment, QPOP generated second-line options will be informed to treating physicians and the physician will exercise his/her discretion to select the most suitable drug based on patient's comorbidities and organ function after a formal molecular/phenotype tumour board.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of radiological response	complete and partial clinical response, including confidence intervals.	3 years
Primary	Percentage of patients with successful organoid generation for each different tumour type.	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.	3 years
Primary	Efficacy of second-line therapy	measured by Overall Response Rate for patients with gastric cancer.	3 years
Secondary	Haematologic and non-haematologic toxicities	Toxicity rating using the NCI CTC v4.03 scale	3 years