A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With Gemcitabine and Nab-paclitaxel or Gemcitabine Combined With Nab-paclitaxel in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer
This is a single-center, prospective, two cohort study to evaluate the efficacy and safety of surufatinib in combination with AG or AG alone in the first-line treatment of patients with locally advanced or metastatic pancreatic cancer. Participants with previously received AG chemotherapy for 2 cycles with no disease progression will be enrolled: Arm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression/death/withdrawn; Arm 2: AG chemotherapy (q3w) until disease progression/death/withdrawn; During the treatment period, imaging methods were used to evaluate the tumor status every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death (during the patient's treatment) or toxicity was intolerable or other criteria for termination of study treatment specified in the protocol were met, and the tumor treatment and survival status after disease progression were recorded. Safety observation indicators include: AEs, changes in laboratory values, vital signs, and changes in electrocardiogram.
• Subjects must meet all of the following criteria for enrollment:
• The subjects voluntarily joined the study and signed the informed consent with good compliance and follow-up;
• Unresectable, locally advanced or metastatic pancreatic cancer confirmed by histopathology or cytology;
• Aged between 18 and 75 (including 18 and 75), male or female;
• ECOG score: 0-1; Expected survival ≥12 weeks;
• Patients who had previously received 2 cycles of AG regimen first-line systemic therapy for locally advanced or metastatic pancreatic cancer and whose efficacy was evaluated as CR, PR, SD (excluding SD patients whose efficacy was evaluated as increased after 2 cycles of therapy);
• Patients with postoperative distant metastasis had received adjuvant chemotherapy of one type and the distance from adjuvant therapy time \> Patients with recurrence at 6 months could be included in the group;
• At least one measurable lesion (according to RECIST 1.1 criteria); Magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement accurately measured the diameter of ≥10mm, conventional CT scan to determine the diameter of at least 20mm.
• No serious organic diseases of heart, lung, brain and other organs;
• The functions of major organs and bone marrow are basically normal:
∙ Blood routine: white blood cells ≥ 4.0 x 109/L, neutrophils ≥ 1.5 x 109/L, platelets ≥ 80 x 109/L, hemoglobin ≥ 90g/L;
‣ International Standardized ratio (INR) and activated partial thrombin time (APTT) ≤1.5× upper limit of normal value (ULN);
‣ Liver function: serum total bilirubin ≤ 1.5 x ULN, ALT/AST ≤ 3 x ULN, serum total biliary red ≤ 1.5 x ULN after internal/external drainage for obstructive jaundice;
‣ Renal function: serum creatinine ≤ 1.5 x ULN, creatinine clearance (CCr) ≥ 50mL/min;
‣ Normal cardiac function, left ventricular ejection fraction (LVEF)≥50% by two-dimensional echocardiography;
⁃ Fertile male or female patients volunteered to use effective contraceptive methods, such as double screen contraceptives, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and within 6 months of the last study medication. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause or sterilization.
• Those who met each of the above criteria were included in the study.