RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Shandong Cancer Hospital and Institute • ClinicalTrials.gov ID: NCT07683221

Registry updated: 2026-10-13

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Description

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.

Interventions

SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy (Drug)
Participants 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.

Eligibility criteria

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.

Conditions

Pancreatic Cancer

Locations

Shandong Cancer Hospital and Institute — Jinan, Shandong, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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