Unresectable Pancreatic Cancer Clinical Trial
Official title:
A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | October 31, 2025 |
Est. primary completion date | October 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
Japan | Tohoku University Hospital | Sendai-shi, Miyagi | |
Japan | Tokyo Medical University Hospita | Shinjuku-ku, Tokyo | |
Japan | Toyama University Hospital | Toyama-shi, Toyama | |
Japan | Wakayama Medical University Hospital | Wakayama-shi, Wakayama | |
Japan | Kanagawa Cancer Center | Yokohama-shi, Kanagawa | |
Japan | Yokohama City University Medical Center | Yokohama-shi, Kanagawa |
Lead Sponsor | Collaborator |
---|---|
SONIRE Therapeutics Inc. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Up to approximately 24 months | ||
Secondary | Progression-free survival | Up to approximately 12 months | ||
Secondary | 1-year survival rate | Up to approximately 12 months | ||
Secondary | Objective response rate | Up to approximately 12 months | ||
Secondary | Disease control rate | Up to approximately 12 months | ||
Secondary | Adverse Events | Up to approximately 12 months |
Status | Clinical Trial | Phase | |
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