Gastric Cancer
Conditions
Interventions
single-arm:modified SOX and i.p. high-dose paclitaxel
Sponsors
Cancer Center, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histopathological or cytological prognosis of adenocarcinoma in gastric or gastroesophageal junction and Her2 (-), or Her2(+) but unacceptable for trastuzumab (physical or economic reasons). 2. With classical image in enhanced CT or MRI that are consistent with peritoneal metastasis of gastric cancer or diagnosed by laparoscopy or exfoliative cytology metastasis at other sites is acceptable but should without gastrointestinal obstruction or immediate decompressive ascites aspiration. 3. No treatment (radiotherapy or chemotherapy) for the metastasis or accepted adjuvant chemotherapy more than one year ago after radical surgery of primary cancer. 4. 18-75 years old adult patients, sex not limited. 5. ECOG score 0-2. 6. Laboratory tests confirmed normal function of bone marrow, liver, kidney and heart within 7 days of the start of treatment. a) Total bilirubin (TBI) = 40 mL/min/1.73 m2; f) INR 1.5 *10^9/L, platelets (PLT) > 75 *10^9/L, hemoglobin (HGB) > 90 g/L; h)ECG is basically normal. 7. The expected survival over three months. 8. Patients volunteered to participate in, and signed the informed consent. 9. Men and women with potential fertility must agree to use effective contraception throughout the study and at least three months after the last treatment.
Exclusion criteria
Exclusion criteria: 1. Anaphylaxis to paclitaxel or any drug in research plan. 2. Pregnant or lactating women. 3. History of other malignant diseases in the last five years. 4. For patients with uncontrolled epilepsy, central nervous system disease or mental disorders, it depends on researchers to determine whether the symptoms hinder the signature of informed consent or affect regular administration of oral drugs. 5. Patients with severe or active heart diseases, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II, severe congestive heart failure, arrhythmia requiring drug intervention and myocardial infarction history in the last 12 months. 6. Patients have some diseases that may affect S-1 absorbing including upper gastrointestinal obstruction or physiological dysfunction and malabsorption syndrome. 7. Patients with peripheral neuropathy which is severer than grade 1 of NCI-CTC AE, but patients only with disappearance of deep tendon reflex (DTR) do not need be excluded. 8. Patients who received organ transplantation require immunosuppressive therapy. 9. Uncontrolled severe infections, massive gastrointestinal bleeding or other serious concomitant diseases. 10. Moderate or severe renal function damage (Creatinine clearance rate upper limit of normal value. 11. People with dihydropyrimidine dehydrogenase (DPD) deficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year OS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Countries
China
Contacts
Public ContactQiu Meng
Cancer Center, West China Hospital, Sichuan University
Outcome results
None listed