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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT03484195
Eligibility Criteria:
Inclusion Criteria
* Age: 18-75years old
* Primary and pathological diagnosis of colon adenocarcinoma
* Radiographic evaluation of initial resectable colon cancer
* T4b colon cancer
* ECOG status: 0～1
* Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
Neutrophil count≥1.5×10\^9/L Platelet count≥90×10\^9/L Hemoglobin≥90g/L Total bilirubin (TBI) ≤ 1.5 \* ULN Alanine aminotransferase (ALT)≤2.5 \* ULN Aspartate aminotransferase (AST)≤2.5 \* ULN Alkaline phosphatase (ALP)≤2.5 \* ULN
* Signed informed consent; able to comply with study and/or follow- up procedures
Exclusion Criteria:
* Previous treatment with oxaliplatin, irinotecan or fluorouracil
* Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
* With distant metastasis
* Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia uncontrolled hypertension. Unexplained syncope occurred within 3 months
* Digestive system diseases that would preclude study treatment or follow-up within the past 6 months
* Gastric ulcers or duodenal ulcers for the treatment of resistance;
* 3 or 4 grade gastrointestinal bleeding / bleeding;
* Gastrointestinal perforation / fistula;
* abdominal abscess;
* Infectious or inflammatory bowel disease
* HIV infection and/or active hepatitis B virus infection
* Pregnant or lactating women. Fertile patients must use effective contraception
* Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study
* Other intervention clinical trials were combined at the same time.
* Nerve or mental abnormality affecting cognitive ability
* Other malignancy except effectively treated squamous cell or basal cell skin cancer,
* Other situations that the researchers think should be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03484195
Study Brief:
Protocol Section:
NCT03484195