A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Summary

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.

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.

Conditions2

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