A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Launched by SONIRE THERAPEUTICS INC. · Oct 27, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with unresectable pancreatic cancer, which means their cancer cannot be surgically removed. The study aims to see how safe and effective a standard chemotherapy treatment is when combined with a novel device called the High Intensity Focused Ultrasound system (Suizenji). This trial is specifically for patients who have not responded well to or cannot tolerate their initial chemotherapy.

To be eligible for the trial, participants must be at least 20 years old and have pancreatic cancer that cannot be removed by surgery. They should also have measurable tumors and be in reasonably good health, as assessed by certain performance status criteria. Participants will receive the assigned treatment and will be monitored for any side effects or improvements in their condition. It’s important to note that individuals with certain conditions, such as multiple active cancers or severe liver issues, may not qualify for this study.

Gender

ALL

Eligibility 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.