Overview
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.
