The goal of this clinical trial is to learn if surufatinib (VEGFR-TKI) plus toripalimab (PD-1 inhibitor) and mFOLFIRINOX (chemotherapy) works as neoadjuvant therapy for patients with high-risk or borderline resectable pancreatic cancer. It will also learn about the safety of the combination regimen. The main questions it aims to answer are:
Does the treatment regimen of surufatinib combined with immunotherapy and chemotherapy could provide further survival benefits for patients with high-risk resectable or borderline resectable pancreatic cancer as neoadjuvant therapy?
Is the safety of this combination therapy tolerable?
Participants will:
Take surufatinib (200mg, qd, po, q2w), Toripalimab (3mg/kg, iv, d1, q2w), Oxaliplatin (68 mg/m², iv, d1, q2w), Irinotecan (135 mg/m², iv, d1, q2w), Calcium folinate (400 mg/m², iv, d1, q2w), 5-FU (2400 mg/m², iv). Treatment for up to 8 cycles.
Visit the clinic once every 8 weeks (± 7 days) for checkups and tests. Keep a diary of their symptoms and record daily medication doses.
Voluntarily sign the informed consent form.
Ages 18-75 years, no gender restrictions.
High-risk features include: ① Imaging findings; ② Significant elevation of CA 19-9 (baseline >210 U/ml, Vincent P Groot, Ann Surg. 2019 Jun;269(6):1154-1162); ③ Large primary tumor (>3 cm, Vincent P Groot, Ann Surg. 2019 Jun;269(6):1154-1162); ④ Large regional lymph nodes (it is recommended to use imaging to assess lymph node metastasis, or if the number of metastatic lymph nodes >3, N2 stage); ⑤ Excessive weight loss (more than 5 kg within 1 month); ⑥ Severe pain (main complaint of abdominal pain is sufficient).
Definition of borderline resectable: ① Arteries: Tumor contact with the celiac trunk (≤180°) or superior mesenteric artery (SMA) (≤180°), or involvement of the hepatic artery that is reconstructable. ② Veins: Narrowing or occlusion of the superior mesenteric vein (SMV)/portal vein (PV), but the proximal/distal vessels are suitable for reconstruction.
Patients with distal metastasis;
Received blood transfusion therapy, blood products and hematopoietic factors such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment;
Received any surgical or invasive treatment or operation within 4 weeks prior to enrollment (except for intravenous catheterization, puncture and drainage, etc.);
Known allergy to any drug in the study;