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Arm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression/death/withdrawn; Arm 2: AG chemotherapy (q3w) until disease progression/death/withdrawn;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.
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;
Participated in clinical trials of other antitumor drugs within 4 weeks before enrollment;
Prior treatment with VEGFR inhibitors or prior treatment with immune checkpoint inhibitors;
Patients with BRCA1/2 germ line mutation;
Patients with obstructive jaundice but failing to reach the expected yellow reduction;