SBRT Followed by Ipilimumab N01, Sintilimab, Nab-Paclitaxel and Gemcitabine for Locally Advanced Pancreatic Cancer

This is a Phase II, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of stereotactic body radiotherapy followed by ipilimumab N01 plus sintilimab in combination with nab-paclitaxel and gemcitabine in patients with locally advanced pancreatic cancer. Eligible patients will receive SBRT followed by sequential systemic therapy. The primary endpoint is progression-free survival, and secondary endpoints include overall survival, disease control rate, duration of response, objective response rate, and safety.

Inclusion Criteria: * Participants voluntarily agree to participate in the study, sign the informed consent form, and are willing and able to comply with study procedures and follow-up. * Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. * Locally advanced unresectable pancreatic cancer without distant metastasis, confirmed by multidisciplinary team evaluation. * Age 18 to 75 years, inclusive. * Eastern Cooperative Oncology Group performance status of 0 to 1. * Life expectancy of at least 3 months. * No prior systemic therapy for advanced pancreatic cancer. * At least one measurable lesion according to RECIST 1.1. Exclusion Criteria: * Participation in another anti-cancer drug clinical trial within 4 weeks before enrollment. * Prior targeted therapy or prior treatment with immune checkpoint inhibitors. * Presence of distant organ metastasis, including liver, peritoneal, brain, or meningeal metastasis. * Pregnancy or breastfeeding. * Any condition that, in the investigator's opinion, makes the participant unsuitable for enrollment in this study.