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;
Single group
Surufatinib
DrugSurufatinib: 200 mg orally once daily, continuous dosing, with each 14 days as one treatment cycle
Toripalimab
DrugToripalimab: 3 mg/kg per dose, intravenous infusion over 1 hour, on day 1, with each 14 days as one treatment cycle
mFOLFIRINOX
DrugOxaliplatin: 68 mg/m² intravenous infusion over 2 hours, on day 1; Irinotecan: 135 mg/m² intravenous infusion over more than 30-90 minutes, on day 1; Calcium folinate: 400 mg/m² intravenous infusion over 2 hours, on day 1; 5-FU: 2400 mg/m² continuous intravenous infusion over 46 hours; With each 14 days as one treatment cycle; Neoadjuvant treatment for up to 8 cycles.
12-month Event Free Survival Rate
Event-free survival (EFS) is defined as the time from enrollment to the first occurrence of any of the following events, including (1) disease progression according to RECIST criteria, (2) undergoing R2 resection surgery, (3) disease recurrence after surgery, or (4) death from any cause. The 12-month EFS rate is defined as the proportion of patients among the total enrolled who have not experienced any of the above predefined events within 12 months from enrollment.
R0 Resection Rate
The proportion of patients whose postoperative pathological evaluation shows no residual tumor cells at all surgical margins (R0) among all patients who underwent surgery after receiving neoadjuvant therapy.
Objective Response Rate
Refers to the proportion of patients whose tumors shrink by a certain amount and maintain it for a certain period of time, including cases of CR and PR. The objective response rate is evaluated using the RECIST 1.1. Subjects must have measurable tumor lesions at enrollment, and the efficacy evaluation criteria according to RECIST 1.1 are classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).
Disease Control Rate
Refers to the percentage of patients with complete response, partial response, and stable disease maintained for more than 4 weeks among those evaluable for efficacy.
Recurrence Free Survival
Recurrence-free survival (RFS) refers to the time interval from the date of surgery following neoadjuvant therapy to the recurrence of the tumor (including local/regional recurrence or distant metastasis) or death from any cause.
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