Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of customized treatment according to BRCA1 assessment in patients with advanced gastric cancer

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Criteria

Inclusion Criteria:

• Provision of informed consent

• Female or male aged 18 years and over

• Histologic or cytologic confirmation of advanced gastric cancer

• Stage III-IV (AJCC 7th)

• ECOG: 0-2

• Have tumor sample that can be tested for BRCA1 mRNA expression

• Negative pregnancy test for women of childbearing potential

• Neutrophile granulocyte greater than 1.5×10^9/L

• Hemoglobin greater than 10g/dL

• Platelet greater than 100×10^9/L

• Serum bilirubin not greater than 1.5x upper limit of reference range (ULRR)

• ALT or AST not greater than 1.5x ULRR

• Creatinine clearance no less than 60ml/min

Exclusion Criteria:

• Have at least another primary malignant tumor

• Active infection

• Chemotherapy with experimental drug within 3 weeks before the start of study therapy

• Women who are pregnant or breast feeding

• Weight loss greater 10% within 6 weeks before the start of study therapy