A Randomized Controlled Study of Suizenji in Patients with Unresectable Pancreatic Cancer

JRCT ID: jRCT2032220428

Registered date:29/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable pancreatic cancer
• Date of first enrollment: 31/01/2023
• Target sample size: 90
• Study type: Interventional

Intervention(s)

- HIFU (High-Intensity Focused Ultrasound) + chemotherapy group:
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
- Chemotherapy group:
Chemotherapy (physician's choice): Nal-IRI/FL, mFOLFIRINOX or Gem/nab-PTX

Outcome(s)

• Primary Outcome: Overall Survival
• Secondary Outcome: Progression-free survival (PFS), 1-year survival rate, objective response rate (ORR), disease control rate (DCR), Adverse Events (AEs), etc.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Ages 20 years and over.
(2) Unresectable pancreatic cancer (including metastatic pancreatic cancer) who are refractory or intolerant to first-line chemotherapy. Any first-line chemotherapy is acceptable.
(3) 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.
(4) Has primary tumor site of measurable lesion according to RECIST guidelines version 1.1
(5) ECOG performance status of 0 to 2.

Exclude criteria

(1) Active multiple cancers that require treatment.
(2) Suspected gastrointestinal invasion of the primary tumor based on CT scan.
(3) Obstructive jaundice. However, patients who have a bile duct stent placed for obstructive jaundice by the time of allocation may be enrolled.
(4) Child-Pugh Classification B or C liver failure due to liver metastases.
(5) Tumor embolization in the veins surrounding the pancreas.
(6) Cystic component within the pancreatic cancer.
(7) Peritoneal dissemination.
(8) Pleural effusion or ascites with poorly controlled
(9) Contraindications to the use of secondary chemotherapy used in this study.

Related Information

• Primary Sponsor: Iwasaki Seinori