A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Last updated: April 2, 2025
Sponsor: SONIRE Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Treatment

mFOLFIRINOX

Nal-IRI/FL

Suizenji

Clinical Study ID

NCT05601323
Sonire-PAC-001
  • Ages > 20
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Ages 20 years and over.

  • Unresectable pancreatic cancer (including metastatic pancreatic cancer) who arerefractory or intolerant to first-line chemotherapy. Any first-line chemotherapy isacceptable.

  • Target treatment tumor is located in the pancreas, and the target tumor can bevisualized with ultrasound echography and can also be treated by high-intensityfocused ultrasound.

  • Has primary tumor site of measurable lesion according to RECIST guidelines version 1.1

  • ECOG performance status of 0 to 2.

Exclusion

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 forobstructive 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.

Study Design

Total Participants: 90
Treatment Group(s): 4
Primary Treatment: mFOLFIRINOX
Phase:
Study Start date:
January 31, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Aichi Medical University Hospital

    Nagakute-shi, Aichi, 480-1195
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai-shi, Miyagi, 980-8574
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospita

    Shinjuku-ku, Tokyo, 160-0023
    Japan

    Active - Recruiting

  • Toyama University Hospital

    Toyama-shi, Toyama, 930-0194
    Japan

    Active - Recruiting

  • Wakayama Medical University Hospital

    Wakayama-shi, Wakayama, 641-8510
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center

    Yokohama-shi, Kanagawa, 241-8515
    Japan

    Active - Recruiting

  • Yokohama City University Medical Center

    Yokohama-shi, Kanagawa, 232-0024
    Japan

    Active - Recruiting

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