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
Histologically or cytologically confirmed high-risk resectable or borderline resectable pancreatic cancer;
18-75 years old (including 18 and 75 years old);
No BRCA1/2 or PALB2 mutation;
No previous pancreatic cancer resection, systemic therapy, or local radiation therapy;
With distant metastasis;
Have received blood transfusion treatment, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment;
Have received any surgery or invasive treatment or operation within 4 weeks before enrollment (except venous catheterization, puncture and drainage, etc.);
Allergic to the study drug or any of its adjuvants;
Parallel
surufatinib + gemcitabine + nab-paclitaxel
DrugNeoadjuvant 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.
gemcitabine + nab-paclitaxel
DrugNeoadjuvant 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.
Surgical complete resection rate (R0)
This is a complete macroscopic resection of the gross tumor with negative surgical margins
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
Objective Response Rate (ORR)
ORR= Complete response rate + partial response rate
Disease Control Rate (DCR)
DCR= Complete response rate + partial response rate + disease stable rate
Downstaging Rate
To determine the rate of downstaging after preoperative therapy
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