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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of a novel High Intensity Focused Ultrasound device (Code: Suizenji) with or with out of standard chemotherapy in patients with unresectable pancreatic cancer who are refractory or intolerant to first-line chemotherapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SONIRE Therapeutics Inc.

Criteria

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.