The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer (GZH-001)

The Second People's Hospital of Sichuan

Status and phase: Unknown; Phase 2

Conditions: Advanced Gastric Cancer

Treatments: Drug: Oxaliplatin and Capecitabine; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02038621

GZH-001

2ndSichuan

Details and patient eligibility

About

To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old
• male or female
• Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ;
• ECOG performance status score 0-2 ;
• Expected survival time more than three months ;
• Adequate hematologic parameters and liver and kidney function ;
• Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L;
• Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ;
• Renal : serum creatinine ≤ ULN ;
• Informed consent of patients or their agents , and signed informed consent.

Exclusion criteria

• For patients allergic to capecitabine ;
• Patients with CNS metastases
• Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ;
• Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ;
• Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ;
• Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ;
• The researchers believe that this test is not suitable for those who participate .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Capecitabine: 1000mg/m\^2 bid, days 1-14, every 3 weeks until progression/intolerance.

Treatment:

Drug: Oxaliplatin and Capecitabine

Drug: Paclitaxel

B

Placebo Comparator group

Description:

Observation until progression

Treatment:

Drug: Oxaliplatin and Capecitabine

Drug: Paclitaxel