NCT04694404

Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced Gastric Cancer

The Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced or Recurrent Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Aiping Zhou · Unknown
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.

Detailed description

3-week plan of S-1 plus Oxaliplatin has been widely used,but it also has cumulative toxicity.Meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.Untreated elderly patients with advanced or recurrent gastric cancer will receive Oxaliplatin 85 mg/m2 (D1, q2w) and S-1(40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w) as the first-line treatment. We will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in China.The primary endpoint is progression-free survival(PFS), and the secondary endpoints are objective response rate(ORR), overall survival(OS) and the safety.

Conditions

• S-1 Plus Oxaliplatin

Interventions

Type	Name	Description
DRUG	S-1,Oxaliplatin	Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w)

Timeline

• Start date: 2016-05-11
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2021-01-05
• Last updated: 2021-01-05

Locations

1 site across 1 country: China