Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer (ASPC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03662035|
Recruitment Status : Not yet recruiting
First Posted : September 7, 2018
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Pancreatic Cancer||Drug: Apatinib Drug: S-1||Phase 2|
- 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].
- 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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer|
|Estimated Study Start Date :||September 15, 2018|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
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.
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.
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 [ Time Frame: one year. ]Progression-free survival is defined as the time from registration to the earlier of death or disease progression.
- Overall Survival [ Time Frame: one year. ]OS refers to the date of registration to the date of death for any cause.
- Duration of response [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: one year. ]DCR refers to the percentage of patients with confirmed complete remission, partial remission, and disease stabilization (> 8 weeks) who can evaluate efficacy