Clinical trial · Interventional
A Study of Suizenji in Patients With Unresectable Pancreatic Cancer
A Randomized Controlled Study of Suizenji in Patients With Unresectable Pancreatic Cancer
NCT05601323CI-TRIAL-00105542active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gem/nab-PTX | Drug | — | UNRESOLVED |
| mFOLFIRINOX | Drug | — | UNRESOLVED |
| Nal-IRI/FL | Drug | — | UNRESOLVED |
| Suizenji | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HIFU (High-Intensity Focused Ultrasound) + Chemotherapy
- description
- HIFU treatment with Suizenji: up to 2 times per week (1 course) for pancreatic primary lesions; the second course should be at least 60 days apart, up to a maximum of 5 courses. Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
- interventionNames
- Device: Suizenji
- Drug: Nal-IRI/FL
- Drug: mFOLFIRINOX
- Drug: Gem/nab-PTX
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX
- interventionNames
- Drug: Nal-IRI/FL
- Drug: mFOLFIRINOX
- Drug: Gem/nab-PTX
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.