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Study of SBRT and PCX12 for Pancreatic Cancer

This study is looking at a new treatment for locally advanced pancreatic adenocarcinoma (a type of pancreatic cancer) that combines radiation therapy (SBRT) with an immunotherapy called PCX12. Researchers want to see if this combination treatment is safe and tolerable. You might be able to join if you have pancreatic adenocarcinoma that is locally advanced or cannot be removed by surgery, and you have already completed chemotherapy without your cancer getting worse. The study will measure how many side effects people experience and what the highest safe dose of PCX12 is over three years. The current recruitment status is unclear, and the study plans to enroll 24 participants.

Study design
This is a single-center, open-label study with an escalating dosage of PCX12. It plans to enroll 24 participants.
What's involved
Participants will receive standard radiation therapy followed by PCX12 therapy, starting at a lower dose and potentially increasing.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and tolerability for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06217666

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)

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Haoming (Carl) Qiu
~24 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:PCX-12

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Measured over 3 years
+1 more outcome measured

Conditions

Pancreatic Adenocarcinoma

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Pancreatic Adenocarcinoma

NCT06217666

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Rochester

    Rochester, New Yorkno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Haoming Qiu · PRINCIPAL_INVESTIGATOR · University of Rochester

Who to contact

Haoming Qiu
[email protected]
585-275-5863
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])3 years

    The Primary objective of the safety lead in component is to report acute, attributable, gastrointestinal toxicity

  • Maximum tolerable dose [Safety and Tolerability]3 years

    Maximum tolerable dose is defined by less than or equal to 30% dose limiting toxicity (DLT) event rate within a given dose