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 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT04140318
Eligibility Criteria:
Inclusion Criteria:
* pathological confirmed advanced gastric and gastro-esophageal junction adenocarcinoma;
* progression after first-line treatment of fluoropyrimidine and platinum, allow patients progressed on/within 6 months of neoadjuvant/adjuvant treatment; allow local radiotherapy after 21days later;
* 18-75 years old;
* ECOG: 0 or 1;
* has adequate organ function
* writen ICF;
Exclusion Criteria:
* previous treated with taxanes (including paclitaxel, nab-PTX, lipo-PTX, and docetaxel etc..);
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody;
* has known active central nervous system metastatases;
* has received a live vaccine within 4 weeks prior to the first dose of study treatment with any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
* clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), orventricular arrhythmia which need medical intervention.
* hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg. coagulation abnormalities (INR \> 1.5 or APTT \> 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04140318
Study Brief:
Protocol Section:
NCT04140318