RECRUITINGEarly Phase 1INTERVENTIONAL
Feasibility Study of Suizenji, in Patients With Unresectable Pancreatic Ductal Adenocarcinoma (SUNRISE-II)
Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji in Unresectable Pancreatic Ductal Adenocarcinoma Patients
About This Trial
This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system for the treatment of unresectable pancreatic ductal adenocarcinoma. Focused ultrasound therapy uses a number of small ultrasound generators attached to a bowl-shaped ultrasound generator to emit ultrasound waves from outside to inside the body and focus them on a single point where cancerous cells in the pancreas are located. The targeted area is then heated, which kills the pancreatic cancer cells, and as a result, the patient's life may be prolonged. Experience with Suizenji for pancreatic cancer patients has shown that the "heating" is only a warm feeling in the abdomen during the treatment.
Who May Be Eligible (Plain English)
1. Signed an Institutional Review Board (IRB) approved willing to sign a consent form document.
2. Men and women ≥ 18 years of age.
3. Histologically or cytologically diagnosed PDAC.
4. Newly diagnosed unresectable\*, locally advanced or metastatic disease. (\* defined as not "Resectable" and not "borderline resectable" based on "Criteria Defining Resectability at Diagnosis" in NCCN Guideline 2024)
5. Primary tumor accessible to HIFU treatment and visualized on transabdominal ultrasonography.
6. Primary tumor site must be a measurable lesion according to RECIST version 1.1 at baseline.
7. ECOG Performance Status (ECOG-PS) of 0 - 1.
8. Life expectancy ≥ 3 months.
9. your organs (liver, kidneys, etc.) are working well enough based on blood tests defined by:
- Neutrophil count: ≥ 1,500/mm3
- Platelet count: ≥ 50,000/mm3
- Hemoglobin: ≥ 8.0 g/dl
- Cr: ≤ 1.7 mg/dl
- AST, ALT: ≤ 3 x upper limit of normal
- T-Bil: ≤ 2 x upper limit of normal
Who Should NOT Join This Trial:
1. Subjects with any cancers other than PDAC who are on active treatment.
2. Subjects who had any prior chemotherapy or interventions for PDAC.
3. Obstructive jaundice (except for subjects who have a bile duct stent placed for obstructive jaundice prior to initiation of HIFU treatment).
4. Tumor embolization in the veins surrounding the pancreas.
5. Cysts outside of primary pancreatic tumor which may obstruct the HIFU sonication pathway. However, if the cyst is completely surrounded by pancreatic tumor, the subject can be included.
6. Subjects with \> 50% reduction in caliber of the principal hepatic artery and occlusion of the portal vein seen on preoperative screening CT or MRI scan.
7. Allergy to contrast agents (except when manageable by prophylactic steroid).
8. Subjects having a cardiac pacemaker.
9. Congestive heart failure, symptomatic coronary artery disease, arrhythmia poorly controlled by drugs, history of myocardial infarction or unstable angina within the past 6 months.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
1. Signed an Institutional Review Board (IRB) approved informed consent document.
2. Men and women ≥ 18 years of age.
3. Histologically or cytologically diagnosed PDAC.
4. Newly diagnosed unresectable\*, locally advanced or metastatic disease. (\* defined as not "Resectable" and not "borderline resectable" based on "Criteria Defining Resectability at Diagnosis" in NCCN Guideline 2024)
5. Primary tumor accessible to HIFU treatment and visualized on transabdominal ultrasonography.
6. Primary tumor site must be a measurable lesion according to RECIST version 1.1 at baseline.
7. ECOG Performance Status (ECOG-PS) of 0 - 1.
8. Life expectancy ≥ 3 months.
9. Adequate organ function defined by:
* Neutrophil count: ≥ 1,500/mm3
* Platelet count: ≥ 50,000/mm3
* Hemoglobin: ≥ 8.0 g/dl
* Cr: ≤ 1.7 mg/dl
* AST, ALT: ≤ 3 x upper limit of normal
* T-Bil: ≤ 2 x upper limit of normal
Exclusion Criteria:
1. Subjects with any cancers other than PDAC who are on active treatment.
2. Subjects who had any prior chemotherapy or interventions for PDAC.
3. Obstructive jaundice (except for subjects who have a bile duct stent placed for obstructive jaundice prior to initiation of HIFU treatment).
4. Tumor embolization in the veins surrounding the pancreas.
5. Cysts outside of primary pancreatic tumor which may obstruct the HIFU sonication pathway. However, if the cyst is completely surrounded by pancreatic tumor, the subject can be included.
6. Subjects with \> 50% reduction in caliber of the principal hepatic artery and occlusion of the portal vein seen on preoperative screening CT or MRI scan.
7. Allergy to contrast agents (except when manageable by prophylactic steroid).
8. Subjects having a cardiac pacemaker.
9. Congestive heart failure, symptomatic coronary artery disease, arrhythmia poorly controlled by drugs, history of myocardial infarction or unstable angina within the past 6 months.
10. Subjects with peritoneal dissemination.
11. Active infections requiring systemic treatment.
12. Pregnancy or women of childbearing potential not willing to follow the birth control as described in the informed consent and/or who are breastfeeding.
13. Received unapproved or investigational drug or device within 30 days of the subject's study start date.
14. The judgment of the investigator would make the subject inappropriate for entry into the study.
Treatments Being Tested
DEVICE
Suizenji (an ultrasound-guided HIFU therapy system)
Suizenji (an ultrasound-guided HIFU therapy system)
DRUG
Nal-IRI/FL
Standard of care
DRUG
mFOLFIRINOX adjuvant chemotherapy
standard of care
DRUG
Gem/nab-PTX
standard of care
Locations (1)
Stanford University
San Francisco, California, United States