NCT01811277

SOX Sequential S-1 in Advanced Biliary Tract Carcinoma（BTC）and Pancreatic Cancer

Phase II Exploratory Study of S-1 Combined With Oxaliplatin Sequential S-1 Single-agent First-line Treatment of Unresectable Metastatic or Locally Advanced Biliary System, Periampullary Cancer and Pancreatic Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory, single-armed, open label study on the efficacy and safety of sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary system or periampullary cancer or pancreatic cancer patients. The primary endpoint is Objective response rate and secondary endpoint is progression free survival , overall survival ,1 year survival rate and safety.

Conditions

• Biliary Tract Cancer
• Periampullary Adenocarcinoma
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	SOX sequential S-1	4-6 cycles SOX followed by S-1 monotherapy until disease progression S-1: 40\~60mg bid，po, d1\~14 （S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-03-14
• Last updated: 2013-03-15

Locations

1 site across 1 country: China