A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

SONIRE Therapeutics

Status: Enrolling

Conditions: Unresectable Pancreatic Cancer

Treatments: Drug: Gem/nab-PTX; Drug: mFOLFIRINOX; Drug: Nal-IRI/FL; Device: Suizenji

Study type: Interventional

Funder types: Industry

Identifiers

NCT05601323

Sonire-PAC-001

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

HIFU (High-Intensity Focused Ultrasound) + Chemotherapy

Experimental group

Description:

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

Treatment:

Device: Suizenji

Drug: mFOLFIRINOX

Drug: Nal-IRI/FL

Drug: Gem/nab-PTX

Chemotherapy

Active Comparator group

Description:

Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX

Treatment:

Drug: mFOLFIRINOX

Drug: Nal-IRI/FL

Drug: Gem/nab-PTX