NCT04135781

Nab-paclitaxel Combined With S-1 as Adjuvant Chemotherapy for Stage Ⅲ Gastric Cancer

Adjuvant Nab-paclitaxel Plus S-1 Versus Capecitabine Plus Oxaliplatin for Patients With Stage III Gastric Cancer After D2 Gastrectomy : a Randomised，Open-label, Phase III Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 616 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage Ⅲ gastric cancer as adjuvant setting

Detailed description

This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage Ⅲ gastric cancer as adjuvant setting. The primary endpoint is the 3-year diseases-free survival (DFS) rate. The secondary endpoints are the overall survival (OS) and safety.

Conditions

• Stomach Cancer

Interventions

Type	Name	Description
DRUG	nab paclitaxel	nab paclitaxel （120mg/m2；iv；d1，8）
DRUG	Tegafur	S-1 （\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg；po；d1-14 bid）
DRUG	Oxaliplatin	Oxaliplatin（130mg/m2 , iv, d1）
DRUG	Capecitabine	Capetabine（1000 mg/m2 po, d1-14 bid ）

Timeline

• Start date: 2020-03-01
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2019-10-23
• Last updated: 2020-03-23

Locations

1 site across 1 country: China