Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer

• Status: Unknown status
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in the Patients with Locally Advanced or Advanced Gastric Cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Hospital of Qinghai University
• Treatments: Albumin-Bound Paclitaxel; Oxaliplatin; Paclitaxel

Criteria

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.