To explore the efficacy and safety of surufatinib in combination with AG regimen verus AG regimen as peri-operative treatment in high - risk resectable or borderline resectable pancreatic cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
106
Neoadjuvant therapy: Surufatinib: 250mg, QD po; Nab-paclitaxel: 125mg/m2, I.V., D1/8, Q3W; Gemcitabine: 1000/m2,I.V., D1/8, Q3W. Adjuvant therapy: Gemcitabine: 1000/m2,I.V., D1/8, Q3W; Capecitabine: 1650-2000mg/(m2·d) bid, po, d1-14, Q3W.
Neoadjuvant therapy: Nab-paclitaxel: 125mg/m2, I.V., D1/8, Q3W; Gemcitabine: 1000/m2,I.V., D1/8, Q3W. Adjuvant therapy: Gemcitabine: 1000/m2,I.V., D1/8, Q3W; Capecitabine: 1650-2000mg/(m2·d) bid, po, d1-14, Q3W.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGSurgical complete resection rate (R0)
This is a complete macroscopic resection of the gross tumor with negative surgical margins
Time frame: about 1 year
Event-free survival (EFS)
The time from randomization to the first event of disease progression that precluded surgery, local or distant recurrence, or death from any cause
Time frame: about 2 years
Objective Response Rate (ORR)
ORR= Complete response rate + partial response rate
Time frame: about 1 year
Disease Control Rate (DCR)
DCR= Complete response rate + partial response rate + disease stable rate
Time frame: about 1 year
Downstaging Rate
To determine the rate of downstaging after preoperative therapy
Time frame: about 1 year
Pathological complete response (pCR) rate
pCR is defined as the absence of residual tumor cells in the pathological examination after resection
Time frame: about 1 year
Overall survival (OS)
Time from randomization to death
Time frame: about 5 years
Adverse events (AEs)
treatment-related adverse events and serious adverse events as assessed by CTCAE v6.0
Time frame: about 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.