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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT04675866
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years old, no gender limit.
2. ECOG 0-1; estimated survival time ≥12 weeks.
3. Histopathologically confirmed unresectable locally advanced or metastatic HER-2 negative gastric adenocarcinoma.
4. At least one measurable lesion (RECIST1.1 standard).
5. Have not received systemic treatment for inoperable or metastatic gastric adenocarcinoma, past (new) adjuvant chemotherapy and adjuvant radiotherapy treatment ended to enrollment\> 6 months.
6. For local lesions (non-target lesions) palliative treatment (mainly local radiotherapy) end time to random entry time\> 2 weeks.
7. The main organs and bone marrow function are basically normal:
1. Routine blood: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥80g/L;
2. Liver function: TBiL≤1.5×ULN; ALT/AST≤2.5×ULN (for patients with liver metastases, ≤5ULN);
3. Renal function: serum creatinine≤1.5×ULN and creatinine clearance rate\>60mL/min;
4. INR≤1.5×ULN and activated partial thromboplastin time ≤1.5×ULN.
8. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF); willing to comply with and able to complete all trial procedures.
9. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age shall take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.
Exclusion Criteria:
1. Patients with symptomatic central nervous system disease or meningeal metastasis; for patients with brain metastases who have received previous treatment, if the clinical condition is stable and imaging evidence does not show disease progression within 4 weeks before the first treatment, they can be considered for inclusion.
2. Patients who have previously been treated with albumin-bound paclitaxel or paclitaxel.
3. Received major surgery (craniotomy, thoracotomy or laparotomy), open biopsy or major traumatic injury within 28 days before enrollment, or expected major surgery during the study treatment period.
4. Suffered from other malignant tumors in the past 5 years (except for cured skin basal cell or squamous cell carcinoma, or carcinoma in situ such as cervix and breast).
5. The investigator believes that it will affect the subjects' ability to receive the treatment of the study protocol and are not controlled for serious medical diseases, such as combined serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Active peptic ulcer, severe infection, etc.
6. Symptomatic congestive heart failure or cardiac color Doppler ultrasound examination shows LVEF (left ventricular ejection fraction \<50%).
7. Any arterial thromboembolic events, including unstable angina pectoris and cerebrovascular accidents, occurred within 6 months before being selected for treatment.
8. A history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before enrollment.
9. Participate in other clinical trials 28 days before enrollment, unless participating in observational (non-interventional) clinical research or in the follow-up phase of interventional research.
10. Patients with a history of interstitial lung disease, non-infectious pneumonia, or active tuberculosis.
11. Patients with congenital or acquired immune deficiency, active hepatitis B or C.
12. The patient is using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes. Those who are still using it within 2 weeks before enrollment.
13. Patients with difficult-to-control effusion, accompanied by severe pleural effusion, abdominal effusion and other clinical symptoms.
14. Patients with grade ≥ 2 sensory or motor neuropathy; patients with peripheral neuropathy NCT-CTCAE ≥ 2.
15. People with a history of psychotropic drug abuse and unable to quit or patients with mental disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04675866
Study Brief:
Protocol Section:
NCT04675866