SBRT followed by a multi-drug immunotherapy and chemo regimen for locally advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, single-arm study enrolling adults with locally advanced pancreatic cancer. Participants receive stereotactic body radiotherapy (SBRT) at 5–10 Gy in five fractions, followed by systemic therapy with ipilimumab, sintilimab, nab-paclitaxel, and gemcitabine. Ipilimumab is given every 6 weeks for four doses, sintilimab every 3 weeks, and nab-paclitaxel with gemcitabine on a 3-week cycle for 6–8 cycles, with sintilimab potentially continuing as maintenance until progression or intolerance. Primary endpoint is progression-free survival, with secondary endpoints including overall survival, disease control rate, duration of response, objective response rate, and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Jinbo Yue, Doctor — Shandong Cancer Hospital and Institute
• Study coordinator: Jinbo Yue, Doctor
• Email: jbyue@sdfmu.edu.cn
• Phone: 0531-67626442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.