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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT03258034
Eligibility Criteria:
Inclusion Criteria:
* ELM gastric cancer as proven histologically under following condition: unable radical excision due to the abdominal aorta a2-b1 or extensive lymph nodes metastatic,
* Definitely diagnosed as above stage of gastric cancer before operation via CT of MRI, ultrasonic endoscopy, PET-CT, or through the laparoscopic exploration if necessary
* Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
* Negative HER-2 state
* ECOG(Eastern Cooperative Oncology Group): 0\~2
* Age: 18\~70 years old- survival time \> 3monts
* Normal hemodynamic indices before the recruitment(including blood cell count and liver/kidney function ). For example: WBC\>4.0\*109/ L, NE\>1.5\*109/L, PLT\>100\*109/L, BIL\<1.5 times of upper limit of normal reference value, ALT and AST\<2.5 times of upper limit of normal reference value, and CRE\<1.2mg/dl
* Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease
* Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver)
* Not participating in other clinical trials before and during the treatment
* Signed the Informed Consent Form
* No peritoneal metastatic and CY0 in 28 days by laparoscopic exploration
* Non-gastric stump cancer
* No esophagus infiltrating or infiltrating less than 3cm
Exclusion Criteria:
* Distal metastasis to Mediastinal lymph node,liver ,peritoneal,pleural effusion ,ascites,above 16a2-b1 and others
* Severe mental illness
* Her-2 positive, desire for hercptin treatment
* Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment
* Allergy to the drugs in this protocol
* Pregnant and lactating women
* Women at childbearing age and of pregnancy desire during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03258034
Study Brief:
Protocol Section:
NCT03258034