Status:
UNKNOWN
Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer
Lead Sponsor:
Affiliated Hospital of Qinghai University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
- Locally advanced, or recurrent, or metastasis disease；
- Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed;
- Life expectancy of at least 3 months;
- ECOG score 0-1;
- Age: 18\~70 years old;
- 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;
- Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases;
- Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver);
- Not participating in other study projects before and during the treatment;
- Voluntarily signed the informed consent.
Exclusion
- Previously treated with first-line chemotherapy;
- Allergy to the drugs in this protocol;
- Pregnant or lactating women;
- Women at childbearing age and of pregnancy desire during the study.
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03263741
Start Date
April 1 2017
End Date
September 1 2020
Last Update
July 8 2019
Active Locations (1)
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1
Affiliated Hospital of Qinghai University
Xining, Qinghai, China, 810000