NCT06217666Not yet recruitingPhase 1
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)
A Phase 1, Prospective, Standard Dose Escalation 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)
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 9 Jan 2024
- Start date
- 1 Dec 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Haoming (Carl) Qiu
- Diseases
- Pancreatic cancer
- NCT number
- NCT06217666
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 1 Dec 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiation treatment or surgical resection of any pancreatic malignancy
Other illness
- Progression of disease or metastatic disease after first line systemic therapy
- Lack of radiographically evident disease after first line chemotherapy
- History of past malignancy
Other
- Inability to tolerate SBRT, Endoscopic ultrasound or IL-12 Injection procedure
- Severe, active comorbidity that shortens the patient's life expectancy to less than 12 weeks
- Patient who is pregnant and/or breastfeeding
- Inability to comply with other required protocol procedures including required biopsies
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.