Gastric Cancer
Conditions
Keywords
Paclitaxel, S-1, Oxaliplatin, Efficiency, safety
Brief summary
Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in the Patients with Locally Advanced or Advanced Gastric Cancer
Detailed description
To assess the Efficiency and safety of Paclitaxel + S-1 + Oxaliplatin(PSOX) in the Patients with Locally Advanced or Advanced Gastric Cancer
Interventions
DRUGPaclitaxel + S-1 + Oxaliplatin
Paclitaxel: 135 mg/m2, iv, 3h, at D1. S-1: S-1: 40mg twice daily for patients with a body surface area (BSA) \< 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to \< 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week. Oxaliplatin: 85 mg/m2, iv, 2h, at D1.
Sponsors
Affiliated Hospital of Qinghai University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma; 2. Locally advanced, or recurrent, or metastasis disease； 3. Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed; 4. Life expectancy of at least 3 months; 5. ECOG score 0-1; 6. Age: 18\ 70 years old; 7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC\>4.0×109/L, NEU \>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; 8. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases; 9. Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver); 10. Not participating in other study projects before and during the treatment; 11. Voluntarily signed the informed consent.
Exclusion criteria
1. Previously treated with first-line chemotherapy; 2. Allergy to the drugs in this protocol; 3. Pregnant or lactating women; 4. Women at childbearing age and of pregnancy desire during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) | 2 years | The sum of complete remission (CR) rate and partial remission (PR) rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival(PFS) | 2 years | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
| Overall survival(OS) | 2 years | From date of enrollment until the date of death from any cause, assessed up to 60 months |
| Disease control rate(DCR) | 2 years | The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year |
Countries
China
Contacts
Primary ContactJiuda Zhao, M.D.
Outcome results
None listed