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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT03400592
Eligibility Criteria:
Inclusion Criteria:
* Advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria:
* Willing to sign ICF
* Above 18 years
* KPS scoreā„70
* Expected survival time more than 90 days
* Subjects with EGFR overexpression (2+ or 3+ in IHC)
* With target lesions in spiral CT or MRI examination within 30 days
* Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent ,platinum agent and Paclitaxel agent.
* Lab test of baseline meet following criteria
* Hemoglobin higher than 9.0g/dL
* Neutrophil higher than 1,500/mm3
* PLT higher than 10.0 104/mm3
* Bilirubin lower than 1.5 times of upper limit of normal range
* AST,ALT,ALP lower than 2.5 times of upper limit of normal range
* Creatinine lower than upper limit of normal range
* When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range
Exclusion Criteria:
* Patients who have received irinotecan
* Patients who are allergic to irinotecan or nimotuzumab.
* Other active malignancy within the last 5 years
* Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
* Investigator judge not eligible to this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03400592
Study Brief:
Protocol Section:
NCT03400592