NCT04258657
Unknown
Phase 2
Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- paclitaxel-albumin and S-1
- Conditions
- Gastric Cancer
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- DFS
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a interventional clinical trial to assess the efficacy and safety of combinational therapy of paclitaxel-albumin and S-1 for the neoadjuvant chemotherapy of advanced gastric cancer.
Investigators
Zhongtao Zhang
Professor
Beijing Friendship Hospital
Eligibility Criteria
Inclusion Criteria
- •pathologically diagnosed gastric adenocarcinoma
- •Type II and III esophageal-gastric-junction malignancy
- •AJCC stage II-III
- •No contraindications for surgery, radical resection can be expected
- •KPS\>60; ECOG score:0-2
- •Expactant survival period\>6 months
- •No other major health issues
- •Lab results within 7 days before inclusion must satisfy:
- •neutrophil≥1.5×109/L
- •PLT≥100×109/L
Exclusion Criteria
- •with other major health issue
- •allergic to relevant drugs
- •experienced any other drug therapy with 4 weeks before inclusion
- •experienced any drug therapy for gastric cancer at anytime
- •diagnosed with any other malignancy within the past 5 years
- •women at child-bearing age; pregnant or breast-feeding women
- •with severe heart disease
- •with upper GI digestion or disrupted absorption
- •with peripheral neural disease
- •with transplated organs or organs having been resected for transplantation
Arms & Interventions
Paclitaxel-albumin and S-1
Intervention: paclitaxel-albumin and S-1
Outcomes
Primary Outcomes
DFS
Time Frame: 3-year
disease free survival
Secondary Outcomes
- ORR(3-year)
- OS(3-year)
Study Sites (1)
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