A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of standard chemotherapy with or without a novel High Intensity Focused Ultrasound system (Code: Suizenji) in patients with unresectable pancreatic cancer who are refractory or intolerant to first-line chemotherapy.

Official Title
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A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Conditions
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Unresectable Pancreatic Cancer

Intervention / Treatment
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* Device: Suizenji
* Drug: Nal-IRI/FL
* Drug: mFOLFIRINOX
* Drug: Gem/nab-PTX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 20 years and over. Unresectable pancreatic cancer (including metastatic pancreatic cancer) who are refractory or intolerant to first-line chemotherapy. Any first-line chemotherapy is acceptable. Target treatment tumor is located in the pancreas, and the target tumor can be visualized with ultrasound echography and can also be treated by high-intensity focused ultrasound. Has primary tumor site of measurable lesion according to RECIST guidelines version 1.1 ECOG performance status of 0 to 2. Exclusion Criteria: Active multiple cancers that require treatment. Suspected gastrointestinal invasion of the primary tumor based on CT scan. Obstructive jaundice. However, patients who have a bile duct stent placed for obstructive jaundice by the time of allocation may be enrolled. Child-Pugh Classification B or C liver failure due to liver metastases. Tumor embolization in the veins surrounding the pancreas. Cystic component within the pancreatic cancer. Peritoneal dissemination. Pleural effusion or ascites with poorly controlled Contraindications to the use of secondary chemotherapy used in this study.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIFU (High-Intensity Focused Ultrasound) + Chemotherapy<br>HIFU treatment with Suizenji: up to 2 times per week (1 course) for pancreatic primary lesions; the second course should be at least 60 days apart, up to a maximum of 5 courses. Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX | Device: Suizenji<br>* HIFU treatment<br>Drug: Nal-IRI/FL<br>* Nanoliposomal irinotecan, Fluorouracil, Levofolinate<br>Drug: mFOLFIRINOX<br>* Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin<br>Drug: Gem/nab-PTX<br>* Gemcitabine, nab-Paclitaxel<br>|
| Active Comparator: Chemotherapy<br>Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX | Drug: Nal-IRI/FL<br>* Nanoliposomal irinotecan, Fluorouracil, Levofolinate<br>Drug: mFOLFIRINOX<br>* Fluorouracil, Levofolinate, Irinotecan, Oxaliplatin<br>Drug: Gem/nab-PTX<br>* Gemcitabine, nab-Paclitaxel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Up to approximately 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Up to approximately 12 months | 
| 1-year survival rate |  | Up to approximately 12 months | 
| Objective response rate |  | Up to approximately 12 months | 
| Disease control rate |  | Up to approximately 12 months | 
| Adverse Events |  | Up to approximately 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable Pancreatic Cancer, Suizenji, high intensity focused ultrasound, HIFU