Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT04611035
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.
Exclusion Criteria:
* There are no specific exclusion criteria if patients meet the inclusion criteria
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT04611035
Study Brief:
Protocol Section:
NCT04611035