The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer

Phase 2

• Conditions: Stage IV Gastric Cancer With Metastasis
• Interventions: Drug: second line chemoregime for advanced gastric cancer

• Registration Number: NCT01964027
• Lead Sponsor: Anhui Medical University

Brief Summary

This study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime.

Detailed Description

The main purposes: to determine the progression-free survival (PFS) and overall survival (OS) of gastric cancer patients given irinotecan + epirubicin as second-line treatment, who are at Stage IV with disease progressed or recurred after first-line chemotherapy failed, ,

The Secondary purposes: to determine disease control rate (Disease Control Rate, DCR), the objective response rate (Object Response rate, ORR) and the Quality of life (Quality Of Life, QOL)

Study Timeline

• Study First Submitted: 2012-01-19
• Status Verified: 2013-10
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-14
• Last Update Submitted: 2013-10-14
• Study First Posted: 2013-10-17
• Last Update Posted: 2013-10-17
• Primary Completion: 2014-07
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irinotecan plus epirubicin	second line chemoregime for advanced gastric cancer	Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment \* 6 cycles as the second line chemoregime for advanced gastric cancer

Primary Outcome Measures

Name	Time	Method
PFS and OS	2 years	Evaluation progression-free survival (PFS) and overall survival (OS); RECIST(Response Evaluation Criteria In Solid Tumors)1.1: 1. Complete response (CR); 2. Partial response (PR); 3. Stable disease(SD) and progression disease(PD); 4. CR + PR is efficient.

Trial Locations

Locations (1)

Department of Oncology,The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China