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

NCT ID: NCT04611035

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2023-01-31

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.

Conditions

Gastrointestinal Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient

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

QPOP

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Peng Yong

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

National University Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Wei Peng Yong

Role: CONTACT

Wei_Peng_Yong@nuhs.edu.sg

6779 5555

Facility Contacts

Wei Peng Yong

Role: primary

Wei_Peng_Yong@nuhs.edu.sg

6779 5555

References

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.

Reference Type: RESULT

PMID: 22810696 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28572459 (View on PubMed)

Other Identifiers

2019/00924

Identifier Type: -

Identifier Source: org_study_id