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

Trial ID: NCT05601323

Interventional - Phase Unknown - Active, not recruiting

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.

Conditions

• Unresectable Pancreatic Cancer

Interventions

• Suizenji
• Nal-IRI/FL
• mFOLFIRINOX
• Gem/nab-PTX

Eligibility

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.

Sponsor

SONIRE Therapeutics Inc.

Source: ClinicalTrials.gov

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