Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)

Starting soon · Phase 1

Conditions studied: Pancreatic Adenocarcinoma

In brief

The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.

Key facts

Study ID

NCT06217666

Run by

Haoming (Carl) Qiu

People needed

24

Starts

2026-12-01

Expected to finish

2029-12-01

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with pathologically proven diagnosis of adenocarcinoma of the pancreas
• After chemotherapy, tumor is determined to be either locally advanced or unresectable by hepatobiliary surgeon; or tumor is considered potentially resectable but subject does not proceed with surgical resection for any reason
• Have completed first line chemotherapy without progression or non-regional metastases
• Tumor is radiographically evident on CT scan after chemotherapy
• Tumor is anatomically amenable to SBRT, e.g. does not directly invade the stomach or bowel
• Tumor is amenable to intra-tumor injection under endoscopic ultrasound guidance
• ECOG performance status 0-2
• Patients with childbearing potential must demonstrate a negative urine or serum pregnancy test
• Male or female subjects, aged at least 18 years; Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the three months after study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year
• Patient must be able to understand and willingly sign study specific informed consent prior to study entry
• Anticipated life expectancy ≥ 12 weeks
• Patients aged at least 18 years of age

You may not qualify if…

• Progression of disease or metastatic disease after first line systemic therapy
• Prior radiation treatment or surgical resection of any pancreatic malignancy
• Inability to tolerate SBRT, Endoscopic ultrasound or IL-12 Injection procedure
• Lack of radiographically evident disease after first line chemotherapy
• Severe, active comorbidity that shortens the patient's life expectancy to less than 12 weeks
• History of past malignancy
• Patient who is pregnant and/or breastfeeding
• Inability to comply with other required protocol procedures including required biopsies

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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