This is a prospective, single-center, single-arm phase 2 study evaluating the efficacy and safety of neoadjuvant surufatinib plus iparomlimab and tuvonralimab injection and nab-paclitaxel/gemcitabine chemotherapy in patients with high-risk resectable or borderline resectable pancreatic cancer. Approximately 56 participants will be enrolled, including about 19 patients with high-risk resectable disease and 37 patients with borderline resectable disease. Participants will receive up to four 21-day cycles of neoadjuvant treatment. Participants considered eligible for surgery will undergo surgical resection approximately 4 weeks after neoadjuvant treatment. After surgery, adjuvant chemotherapy with either gemcitabine plus capecitabine or modified FOLFIRINOX will be selected by the investigators after multidisciplinary team review. The primary outcome is the 12-month event-free survival rate.
Have fully understood this study and voluntarily signed the informed consent form.
Aged between 18 and 75 years inclusive, of any gender.
Have at least one measurable lesion per RECIST 1.1.
No pathogenic BRCA1/2 or PALB2 mutations, or unknown BRCA1/2 and PALB2 mutation status.
Patients with distant metastasis.
Patients who have received blood transfusion, blood products or hematopoietic growth factors (such as albumin and granulocyte colony-stimulating factor [G-CSF]) within 14 days prior to enrollment.
Patients who have undergone any surgery or invasive treatment/procedure within 4 weeks prior to enrollment (except venous catheterization, puncture and drainage, etc.).
Known hypersensitivity to any study drug.
Single group
Surufatinib Plus Iparomlimab and Tuvonralimab and AG Chemotherapy
DrugSurufatinib 200 mg orally once daily; iparomlimab and tuvonralimab injection 5 mg/kg intravenously every 21 days; nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² intravenously on Days 1 and 8 of each 21-day cycle, for up to four cycles.
Gemcitabine plus Capecitabine
DrugAfter surgery, eligible participants may receive gemcitabine 1000 mg/m² intravenously on Days 1 and 8 plus capecitabine 1650-2000 mg/m²/day orally on Days 1-14 of each 21-day cycle.
Modified FOLFIRINOX
DrugAfter surgery, eligible participants may receive oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², and fluorouracil 2400 mg/m² every 14 days.
12-month Event Free Survival (EFS) rate
The starting point is the day of the first dose of neoadjuvant therapy, and observation continues until any of the following events occur (whichever comes first): 1. Disease progression (RECIST 1.1; re-evaluation is allowed if immune-related pseudoprogression is suspected); 2. Failure to complete the planned neoadjuvant therapy; 3. Inability to undergo surgery (including for non-disease reasons) or positive surgical margins; 4. Found to be unresectable during surgery; 5. Death for any reason.
Pathological complete remission rate (pCR)
In patients who underwent surgery after receiving neoadjuvant therapy, no remaining living tumor cells were found in the original tumor site or any regional lymph nodes in the surgical specimens (that is, ypT0N0).
Major pathological remission rate (MPR)
This study defines patients who had surgery after receiving neoadjuvant therapy as having a proportion of remaining viable tumor cells in the resected tumor bed of ≤50% of the tumor bed area.
Objective Response Rate (ORR)
Refers to the proportion of patients whose tumors shrink by a certain amount and maintain that reduction for a certain period, including cases of CR and PR. Tumor objective response is assessed using the solid tumor response evaluation criteria (RECIST 1.1). Subjects must have measurable tumor lesions at baseline, and efficacy evaluation standards according to RECIST 1.1 are classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).
Disease Control Rate (DCR)
The percentage of cases with complete response, partial response, or stable disease lasting more than 4 weeks among patients whose efficacy can be evaluated.
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