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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT00940758
Eligibility Criteria:
Inclusion Criteria:
* Histopathologically confirmed metastatic colorectal cancer
* Documented disease progression after first-line chemotherapy containing oxaliplatin
* Both genders, age 18 years
* ECOG performance status 0 or 1
* Adequate organ and marrow function
* Written informed consent to participate in the study
Exclusion Criteria:
* Have received irinotecan treatment
* With active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
* With clinically significant gastrointestinal disorder (e.g. bleeding, inflammation, obstruction, including partial or complete obstruction secondary to peritoneal carcinomatosis, or diarrhea \> grade 1)
* With uncontrolled intercurrent illness that could limit study compliance considered to be ineligible for the study by the investigators including, but NOT limited to, any of the following:ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia psychiatric illness or social situation that would preclude study compliance
* With other primary malignancies, except those remain disease-free for 3 or more years after curative treatment.
* Prior chemotherapy within 3 weeks
* Major surgery or radiotherapy within 4 weeks
* Prior participation in any investigational drug study within 3 weeks
* History of allergic reaction to liposome product
* Pregnant or breastfeeding (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00940758
Study Brief:
Protocol Section:
NCT00940758