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.
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.
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.
Single group
SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy
DrugParticipants will receive stereotactic body radiotherapy at 5-10 Gy in 5 fractions, followed one week later by sequential systemic therapy with ipilimumab N01, sintilimab, nab-paclitaxel, and gemcitabine. Ipilimumab N01 will be administered at 1 mg/kg intravenously every 6 weeks for a total of 4 doses. Sintilimab will be administered at 200 mg intravenously every 3 weeks. Nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² will be administered on Days 1 and 8 of each 3-week cycle. AG chemotherapy will be given for 6 to 8 cycles, and sintilimab may continue as maintenance therapy until disease progression or other protocol-specified discontinuation criteria.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the initiation of study treatment to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first.
Overall Survival (OS)
Overall survival is defined as the time from initiation of study treatment to death from any cause.
Disease Control Rate (DCR)
Disease control rate is defined as the proportion of participants who achieve complete response, partial response, or stable disease according to RECIST 1.1.
Duration of Response (DoR)
Duration of response is defined as the time from the first documented complete response or partial response to disease progression or death from any cause, whichever occurs first.
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants who achieve complete response or partial response according to RECIST 1.1.
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