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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT02796820
Eligibility Criteria:
Inclusion Criteria:
* The subjects volunteer to sign the informed consent;
* Aged: 18 to 75 years old;
* Colorectal cancer (AJCC-TNM, Stage Ⅰ, low-risk Stage Ⅱand Stage Ⅲ; Patients with Stage Ⅲ colorectal cancer refuse to postoperative adjuvant chemotherapy);
* The diagnosis and colorectal cancer has been confirmed by pathological examination after radical surgery;
* The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT), alkaline phosphatase (ALP)\< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN; normal coagulation function;
* Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): white blood cells count ≥ 3.0×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L;
* ECOG：0-2 points；
* No other previous history of malignancy.
Exclusion Criteria:
* Multiple primary cancer;
* Not recover from the colorectal surgery;
* Presence of organ, bone, or skin metastases;
* Pregnant or lactating women;
* Those with active bleeding due to various reasons;
* Those with HIV infection or AIDS-associated diseases;
* Those with severe acute and chronic diseases;
* Those with severe diabetes;
* Those with serious infectious diseases;
* Those who can not take drugs by oral route;
* Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
* Conditions that are considered not suitable for this study investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02796820
Study Brief:
Protocol Section:
NCT02796820