Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX1… (NCT06217666) | Clinical Trial Compass
Not 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)
United States24 participantsStarted 2026-12-01
Plain-language summary
The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 age…
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])