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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT04694404
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma;
* Aged≥60
* ability of oral administration;
* CT or MRI can be used to assess measurable or non-measurable lesions according to the criteria of Response Evaluation Criteria In Solid Tumours (RECIST 1.1);
* Untreated
* more than 12 months after the last adjuvant/neoadjuvant chemotherapy;
* ECOG=0-2;
* Available organ function: ALT≤2.5xULN;AST≤2.5xULN;If patients have hepaticmetastasis,ALT≤2.5xULN,AST≤2.5xULN;ALP≤2xULN;TBIL≤1.0xULN;NEUT≥1.5×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;Creatinine Clearance≥60ml/min
* Informed consent;
* Expected survival more than 3 months;More than 3 weeks after major surgery.
Exclusion Criteria:
* Neoadjuvant and/or adjuvant have been treated with more than two plans;
* In the past two years, the total dose of oxaliplatin≥800mg/m2;
* Other cancers in the past 5 years,except for cervical carcinoma in situ or non-melanoma skin cancer;
* Symptomatic brain metastases or soft meningeal metastasis;
* Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure;
* Serious complications (including intestinal paralysis, gastrointestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, renal insufficiency and cirrhosis); Chronic nausea, vomiting or diarrhea (more than 4 times per day, or watery);Gastrointestinal bleeding requires regular blood transfusion;HIV or AIDS; Mental illness; Neuropathy grade≥2;Infectious diseases or inflammation, temperature≥38℃;
* Known allergy to drugs in the study;
* Pregnant or lactating women;
* Both male and female subjects of potential fertility have to agree effective birth control during the entire study;
* Experimental drugs used no more than 4 weeks;
* Other conditions the researchers considered ineligible for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04694404
Study Brief:
Protocol Section:
NCT04694404