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:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT04509167
Eligibility Criteria:
Inclusion Criteria:
* 16 years of age or older, male or female
* Life expectancy of at least 3 months
* Confirmed tumor by imaging studies
* Have adequate organ function, as measured by laboratory values: Lymphocyte ratio \>20%; WBC \>3.0×10\^9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; if the patient has liver metastases, ALT and AST ≤5 × ULN; Alkaline phosphatase (ALP）≤2.5 × ULN; total serum bilirubin (TBIL) \< 1.5 × ULN; Urea nitrogen (BUN）≤1.5 × ULN; Creatinine (Cr）1.5≤ULN; Normal blood coagulation function, urine routine, and electrocardiogram (ECG)
* Available tumor specimen for sequencing and neoantigen determination
* Ability to find 3 or more neoantigen epitopes
* Ability to follow research and follow-up procedures
* Able to understand and willing to sign an IRB approved written informed consent document
* Agree with the use of contraception or partner of child-bearing potential agrees to use adequate contraception which will include two of the following: hormonal or barrier method of birth control, or abstinence prior to study entry, for the duration of study participation, and for 30 days following completion of therapy
Exclusion Criteria:
* History of immunodeficiency disorder or autoimmune condition requiring active immunosuppressive therapy
* Evidence of Liver and kidney dysfunction, severe heart disease, or coagulation dysfunction
* Known diagnosis of an infectious condition including hepatitis, HIV, CMV, and Treponema pallidum
* Participant becomes pregnant and/or is breastfeeding or plans on becoming pregnant during study
* A psychiatric illness that would limit compliance with study requirements as determined by the investigator or the investigator believes that participant is not suitable for inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
70 Years
Study:
NCT04509167
Study Brief:
Protocol Section:
NCT04509167