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

Starting soon · Phase 2

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT07683221

Run by

Shandong Cancer Hospital and Institute

People needed

47

Starts

2026-07-15

Expected to finish

2029-07-15

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shandong Cancer Hospital and Institute — Jinan, Shandong, China

Full record on ClinicalTrials.gov

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