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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Apatinib Patients with advanced pancreatic cancer after failure of first-line chemotherapy will receive Apatinib (500mg/d, orally) 30 minutes after meal with warm water.Take 21 days as a cycle, patients will receive this treatment until they have got disease progressed. Dose adjustment: with 3/4 level of adverse reactions, the dose should be lowered to 250 mg/d.
S-1 Patients will receive S-1 (60mg/d for BSA\<1.25m2, 80mg/d for 1.25\<BSA\<1.5m2, and 100mg for BSA \>1.5m2, orally) twice a day, once after breakfast and once after dinner, for 14 days, 7 days for suspension and 21 days as one cycle.
Progression Free Survival
Progression-free survival is defined as the time from registration to the earlier of death or disease progression.
Time frame: one year.
Overall Survival
OS refers to the date of registration to the date of death for any cause.
Time frame: one year.
Duration of response
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).
Time frame: one year.
Objective response rate
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
Time frame: one year.
Disease Control Rate
DCR refers to the percentage of patients with confirmed complete remission, partial remission, and disease stabilization (\> 8 weeks) who can evaluate efficacy
Time frame: one year.
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