Raltitrexed Combined With Oxaplatin as Second Line Treatment for Advanced Malignant Biliary System Tumor
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- PFS（Progression Free Survival）
Study Overview
Brief Summary
The purpose of this study was to explore the safety and efficacy of raltitrexed combined with oxaplatin as second line treatment for advanced malignant biliary system tumor.
Detailed Description
The purpose of this study was to explore the safety and efficacy of raltitrexed combined with oxaplatin as second line treatment for advanced malignant biliary system tumor. Single arm，phase II study for patients with cholangiocarcinoma or gallbladder carcinoma after first line treatment failure to explore effection and safety of raltitrexed combined with oxaplatin as second line treatment；Sample size：50.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
RALOX
Raltitrexed combined with oxaplatin
Intervention: Raltitrexed combined with oxaplatin (Drug)
Outcomes
Primary Outcomes
PFS（Progression Free Survival）
Time Frame: 24 months
PFS is defined as the time interval from initiation of treatment to the first date of documented tumor progression or death from any cause, whichever occurs first.
Secondary Outcomes
- DCR(24 months)
- Qol ( quality of life )(24 months)
- AE(12 months)
- ORR(24 months)
- OS(36 months)