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

NCT01811277 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-03-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Peking University

    lead OTHER

Principal Investigators

  • Lin Shen, Prof. · Peking University Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01811277 on ClinicalTrials.gov