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 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT02882659
Eligibility Criteria:
Inclusion Criteria:
1. Capable and willing of providing signed informed consent before study
2. Patient age ≥20 at date of consent
3. Performance status (ECOG) ≤2
4. Patients have a life expectancy of \> 3 months
5. Patients agree to be in compliant to clinical protocol planned treatment plan
6. Histologically confirmed metastatic solid tumor, including colon cancer, gastric cancer, pancreatic cancer, bile duct cancer, liver cancer
7. Patient with histological and conventional imaging proven measurable lesion
8. Patients not pregnant. All male and female patients with reproduction ability should use appropriate contraception method(s) during the study period
9. Patient is not currently under immunosuppressive treatment for previous or recurred autoimmune disease
10. Patient should have received and failed prior standard cancer therapies (according to TVGH standard cancer treatment procedures, or National Comprehensive Cancer Network clinical practice guidelines in oncology)
11. Patient with adequate hematology function:
Absolute neutrophil count (ANC) ≥ 1,500 cells Total white blood cell (WBC) ≥ 3,000 cells /mm3 Hemoglobin ≥ 9 g/dl Platelets ≥ 100,000 counts /mm3
12. Patient with adequate hepatic and renal function Serum creatinine ≤ 1.5X Upper Limit of Normal (ULN) Total bilirubin (TB) ≤ 1.5X ULN, or ≤ 2.5X ULN for patients with primary HCC or liver metastasis ALT and AST ≤ 2.5X ULN, or ≤ 5X ULN for patients with primary HCC or liver metastasis Alkaline phosphatase (ALP) ≤ 5X ULN
13. Patient showing negative response in syphilis, HIV, HBV and HCV test
Exclusion Criteria:
1. Any other investigational drug used within 28 days prior to first DKC administration
2. Patient with known brain metastasis or metastasis to central nervous system
3. Patient with pulmonary fibrosis
4. Patient with pleural effusion or as cites correspond to CTCAE grading \> 2
5. Patient with uncontrolled disease including but not limit to cardiovascular disease, liver disease, renal disease or infectious disease
6. Patients being diagnosed with any cognitive or psychiatric illness
7. Patient not suitable to participate the trial for safety concerns as judged by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02882659
Study Brief:
Protocol Section:
NCT02882659