This study is designed to explore the efficacy and safety of surufatinib combined with gemcitabine and nab-paclitaxel as peri-operative treatment in locally advanced or borderline resectable pancreatic cancer.
This is a phase II, multi-centered, open-label study, aims to explore the efficacy and safety of surufatinib (250mg, qd po) combined with gemcitabine (1000mg/m2, I.V, d1/8/15, Q4W) and nab-paclitaxel (125mg/m2, I.V, d1/8/15, Q4W) as peri-operative treatment in locally advanced or borderline resectable pancreatic cancer. Potential therapeutic biomarkers will also be explored.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
surufatinib: 250mg, QD po; nab-paclitaxel: 125mg/m2, I.V., D1/8/15, Q4W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1/8/15, Q4W
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Surgical complete resection rate (R0)
This is a complete macroscopic resection of the gross tumor with negative surgical margins
Time frame: about 2 years
Objective Response Rate (ORR)
ORR= Complete response rate + partial response rate
Time frame: about 2 years
Disease Control Rate (DCR)
DCR= Complete response rate + partial response rate + disease stable rate
Time frame: about 2 years
Downstaging Rate
To determine the rate of downstaging after preoperative therapy
Time frame: about 2 years
Surgical Resection Rate
To determine the rate of surgical resection after preoperative therapy
Time frame: about 2 years
Pathological complete response (pCR) rate
pCR is defined as the absence of residual tumor cells in the pathological examination after resection
Time frame: about 2 years
Major pathological response (MPR)
MPR is defined as less than 10% residual tumor after neoadjuvant therapy
Time frame: about 2 years
Overall survival (OS)
OS: from the initial date of neoadjuvant therapy to the date of death due to any cause. Patients without documentation of death at the time of analysis will be censored at the last follow-up date. Estimated using Kaplan-Meier method.
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Time frame: about 5 years
Recurrence Free Survival (RFS)
RFS: from the initial date of neoadjuvant treatment to the first date of radiologic recurrence or death after perioperative treatment.
Time frame: about 3 years
Disease-free survival (DFS)
DFS: from the initial date of neoadjuvant treatment to the date of disease recurrence or death, whichever is earlier.
Time frame: about 3 years
Adverse events (AEs)
treatment-related adverse events and serious adverse events as assessed by CTCAE v5.0
Time frame: about 2 years