Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer
- Registration Number
- NCT03662035
- Lead Sponsor
- Changzhou No.2 People's Hospital
- Brief Summary
The aim of this study was to determine the efficacy and safety of apatinib combined with S-1 on advanced pancreatic cancer patients after failure of first-line chemotherapy.
- Detailed Description
1. To observe the curative efficacy of apatinib and S-1 on patients by analyzing the data of overall survival (OS), complete remission (CR) or partial remission (PR), the rate of progression free survival (PFS), levels of CA19-9 and VEGFR in serum \[Time Frame: Evaluation at 2 month intervals through study completion from the date of study entry until the date of progression, up to 1 year\].
2. To observe any adverse events, including abnormal clinical symptoms and vital signs, abnormal laboratory examinations, and to record the clinical features, severity, occurrence time, duration, management and prognosis of all subjects during the clinical study, and to determine the correlation between these adverse events and the experimental drugs. . The safety of drugs used in advanced pancreatic cancer was evaluated by CTCAE v4.0
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single-arm S-1 Apatinib and S-1 Patients will be offered with Apatinib (500mg/d) and S-1 (60mg/d for BSA\<1.25m2, 80mg/d for 1.25\<BSA\<1.5m2, and 100mg for BSA \>1.5m2) until their disease have progressed. single-arm Apatinib Apatinib and S-1 Patients will be offered with Apatinib (500mg/d) and S-1 (60mg/d for BSA\<1.25m2, 80mg/d for 1.25\<BSA\<1.5m2, and 100mg for BSA \>1.5m2) until their disease have progressed.
- Primary Outcome Measures
Name Time Method Progression Free Survival one year. Progression-free survival is defined as the time from registration to the earlier of death or disease progression.
- Secondary Outcome Measures
Name Time Method Overall Survival one year. OS refers to the date of registration to the date of death for any cause.
Duration of response one year. DOR refers to the time from the time the measurement first conforms to the CR or PR criteria (whichever is first measured) to the time the first true record of disease recurrence or progression (using the minimum measurements recorded in the trial as a reference for disease progression).
Objective response rate one year. ORR refers to the proportion of patients whose tumors have shrunk to a certain extent for a certain period of time, including CR and PR cases
Disease Control Rate one year. DCR refers to the percentage of patients with confirmed complete remission, partial remission, and disease stabilization (\> 8 weeks) who can evaluate efficacy