NCT04217096

Efficacy and Safety of Paclitaxel Liposome and S-1 as First-line Therapy in \ Advanced Pancreatic Cancer Patients

A Single-arm, Prospective Study to Evaluate the Efficacy and Safety of the Combination of Paclitaxel Liposome and S-1 as First-line Therapy in Treating Patients With Advanced Metastatic Pancreatic Cancer

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The present study is intended to investigate the efficacy and safety of the patients with confirmed advanced pancreatic cancer after treating with the combination of paclitaxel liposome plus S-1.

Detailed description

Allocation: Non-randomized Endpoint Classification: Efficacy/ Safety Study Intervention Model: single arm Masking: Open Lable Primary Purpose: Treatment

Conditions

• Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel liposome	Patients receive paclitaxel liposome 175 mg/m\^2 (iv, 3h) on day 1 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic
DRUG	S-1	Patients receive S-1 at a dose according to the body surface area（\<1.25m\^2，40mg Bid；1.25\~1.5m\^2,50mg Bid；\>1.50m\^2,60mg Bid）on days 1-14 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-09-30
• Completion: 2023-03-31
• First posted: 2020-01-03
• Last updated: 2020-01-03

Locations

1 site across 1 country: China