Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT06217666
Eligibility Criteria:
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 aged at least 18 years of age
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06217666
Study Brief:
Protocol Section:
NCT06217666