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New treatment option for Pancreatic Cancer
Official title Feasibility Study of Suizenji, in Patients With Unresectable Pancreatic Ductal Adenocarcinoma (SUNRISE-II)
ClinicalTrials.gov ID: NCT07033689
What this study is testing
What is Nal-IRI/FL?
Nal-IRI/FL is an investigational medicine, being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed an Institutional Review Board (IRB) approved informed consent document.
- Men and women ≥ 18 years of age.
- Histologically or cytologically diagnosed PDAC.
- Newly diagnosed unresectable\ , locally advanced or metastatic disease. (\ defined as not "Resectable" and not "borderline resectable" based on...
- Primary tumor accessible to HIFU treatment and visualized on transabdominal ultrasonography.
You likely can't join if
- people with any cancers other than PDAC who are on active treatment.
- people who had any prior chemotherapy or interventions for PDAC.
- Obstructive jaundice (except for people who have a bile duct stent placed for obstructive jaundice prior to initiation of HIFU treatment).
- Tumor embolization in the veins surrounding the pancreas.
- Cysts outside of primary pancreatic tumor which may obstruct the HIFU sonication pathway. However, if the cyst is completely surrounded by pancreatic...
- people with \> 50% reduction in caliber of the principal hepatic artery and occlusion of the portal vein seen on preoperative screening CT or MRI...
See the full eligibility criteria
- Signed an Institutional Review Board (IRB) approved informed consent document.
- Men and women ≥ 18 years of age.
- Histologically or cytologically diagnosed PDAC.
- 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)
- Primary tumor accessible to HIFU treatment and visualized on transabdominal ultrasonography.
- Primary tumor site must be a measurable lesion according to RECIST version 1.1 at baseline.
- ECOG Performance Status (ECOG-PS) of 0 - 1.
- Life expectancy ≥ 3 months.
- 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
- people with any cancers other than PDAC who are on active treatment.
- people who had any prior chemotherapy or interventions for PDAC.
- Obstructive jaundice (except for people who have a bile duct stent placed for obstructive jaundice prior to initiation of HIFU treatment).
- Tumor embolization in the veins surrounding the pancreas.
- 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.
- people with \> 50% reduction in caliber of the principal hepatic artery and occlusion of the portal vein seen on preoperative screening CT or MRI scan.
- Allergy to contrast agents (except when manageable by prophylactic steroid).
- people having a cardiac pacemaker.
- Congestive heart failure, symptomatic coronary artery disease, arrhythmia poorly controlled by drugs, history of myocardial infarction or unstable angina within the past 6 months.
- people with peritoneal dissemination.
- Active infections requiring systemic treatment.
- Pregnancy or women of childbearing potential not willing to follow the birth control as described in the informed consent and/or who are breastfeeding.
- Received unapproved or investigational drug or device within 30 days of the subject's study start date.
- The judgment of the investigator would make the subject inappropriate for entry into the study.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.