Phase
Condition
Stomach Cancer
Digestive System Neoplasms
Esophageal Disorders
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
histologically confirmed unresectable advanced or recurrent diffuse-type or mixed-typegastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
18 years old to 75 years old, able to conduct oral administration.
Measurable disease or non-measurable but evaluable disease, according to the ResponseEvaluation Criteria in Solid Tumours(RECIST 1.1)
No palliative chemotherapy and radiotherapy. Previous adjuvant or neoadjuvantchemotherapy , if applicable, more than 12 months.
ECOG systemic status score of 0 to 2.
normal organ function, that meet the following criteria:
ALT and AST(≤2.5 times ULN (≤5 times ULN in patients with liver metastases)
ALP ≤ 2 times ULN ; (for patients with liver metastases can be no limit to theALP).
Total bilirubin ≤ 1 times ULN.
Absolute neutrophil count ≥ 2.0 × 10^9 / L.
Platelet count ≥ 100 × 10^9 / L.
Hemoglobin ≥ 80g / L.
Creatinine ≤ 1.25 times ULN.
The estimated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula).
Signed informed consent, treatment, follow-up and inspection in accordance with thestudy protocol.
Life expectancy greater than 3 months.
At least 3 weeks after major surgery.
Exclusion
Exclusion Criteria:
Previous adjuvant or neoadjuvant chemotherapy within the prescribed time
the investigator determines that the patient is not suitable for participation in thisstudy, and specifically includes (but is not limited to):
The past five years there have been other malignancies, but after appropriatetreatment of cervical carcinoma in situ and non-melanoma skin cancer.
brain metastases or leptomeningeal metastasis.
myocardial infarction (within the past six months), severe unstable angina,congestive heart failure.
Serious complications (including paralytic ileus, intestinal obstruction,interstitial pneumonia, lung fibrosis, beyond the control of diabetes, renalinsufficiency and cirrhosis of the liver, etc.).
Chronic nausea, vomiting, or diarrhea (per day greater than or equal to 4 timesor watery stools).
Gastrointestinal bleeding, and need for frequent blood transfusions.
human immunodeficiency virus (HIV) carrier or suffering from AIDS (AIDS).
Suffering from a mental illness.
neuropathy severity ≥grade 2 .
Infectious disease or inflammation, body temperature ≥ 38 ℃.
Cisplatin, oxaliplatin, or S-1 allergy.
Pregnancy or breast-feeding women.
refused to take appropriate contraceptive measures (including male patients).
Under experimental drug within 4 weeks.
Under other anti-cancer treatment.
HER2 IHC(3+) or IHC(2+) /FISH(+)
Study Design
Study Description
Connect with a study center
Sun Yat-sen University Cancer Center
Gaungzhou, Guangdong 510060
ChinaSite Not Available
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available

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