RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor
- Registration Number
- NCT05148143
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RALOX Raltitrexed combined with oxaplatin Raltitrexed combined with oxaplatin
- Primary Outcome Measures
Name Time Method PFS（Progression Free Survival） 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 Outcome Measures
Name Time Method ORR 24 months Overall Response Rate
OS 36 months Overall Survival
DCR 24 months Disease Control Rate
Qol ( quality of life ) 24 months EORTC-QLQ-C30 is a cancer-specific instrument
AE 12 months Adverse Event
Trial Locations
- Locations (1)
the Second Affiliated Hospital of Medical College of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China