Suizenji for Pancreatic Cancer

Overseen By Minako Koga

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: SONIRE Therapeutics Inc.

Disqualifiers: Other cancers, Prior chemotherapy, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Suizenji, which uses focused ultrasound waves to target and heat pancreatic cancer cells. This approach may extend the lives of those with pancreatic ductal adenocarcinoma that cannot be surgically removed. The trial aims to determine if this method is safe and effective. Suitable participants have pancreatic cancer that cannot be surgically removed, and the tumor must be visible with an ultrasound. As an Early Phase 1 trial, participants will be among the first to receive this innovative treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Suizenji device is safe for treating pancreatic cancer?

Research has shown that Suizenji, a type of high-intensity focused ultrasound (HIFU) therapy, is generally well-tolerated by patients with pancreatic cancer. In previous studies, patients mostly experienced a warm sensation in their abdomen during treatment, indicating minimal discomfort. The studies available have reported no major side effects.

As this is an early-phase trial, the primary goal is to assess the safety and tolerability of the treatment. Early-phase trials typically mark the first time a new treatment is tested in people, so researchers monitor safety very closely. Suizenji's breakthrough device designation from the FDA for treating pancreatic cancer suggests confidence in its safety, based on past research and use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for pancreatic cancer, such as surgery, chemotherapy, and radiation, Suizenji offers a non-invasive alternative by using an ultrasound-guided High-Intensity Focused Ultrasound (HIFU) therapy system. This technique targets cancer cells with precision, minimizing damage to surrounding healthy tissue. Researchers are excited about Suizenji because it promises fewer side effects and potentially faster recovery times, making it a promising new option for pancreatic cancer patients.

What evidence suggests that the Suizenji device is effective for pancreatic cancer?

Research shows that high-intensity focused ultrasound (HIFU) therapy, such as Suizenji, can effectively treat pancreatic cancer. Past studies have proven that HIFU safely targets and destroys cancer cells by heating them, which can help extend life. In this trial, participants will receive the Suizenji system, which focuses ultrasound waves on cancer cells in the pancreas, heating them to kill the cells without surgery. Users of Suizenji report feeling only a warm sensation in the abdomen during treatment, making it less invasive than other options. While information on Suizenji is still developing, the technology is already recognized for its potential in treating pancreatic cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Pejman Ghanouni, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for patients with pancreatic ductal adenocarcinoma that cannot be surgically removed. Participants should meet specific health criteria not detailed here.

Inclusion Criteria

My cancer cannot be surgically removed and has spread.

Signed an Institutional Review Board (IRB) approved informed consent document

Life expectancy ≥ 3 months

Exclusion Criteria

Allergy to contrast agents (except when manageable by prophylactic steroid)

My liver's main artery is significantly narrowed and the portal vein is blocked, as seen on scans.

The judgment of the investigator would make the subject inappropriate for entry into the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

HIFU Treatment

Participants receive the Suizenji HIFU treatment to target pancreatic cancer cells

1 day for initial session, additional sessions if required

Chemotherapy

Standard 1st line chemotherapy is initiated after HIFU treatment

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Follow-up visits at Month 1 and Month 3

Long-term Follow-up

Participants are monitored long-term for survival and disease progression

Until death or up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Suizenji

Trial Overview The study tests 'Suizenji', a device using ultrasound waves to heat and kill cancer cells in the pancreas, alongside standard chemotherapy treatments like Gem/nab-PTX, Nal-IRI/FL, and mFOLFIRINOX.

How Is the Trial Designed?

Group I: Suizenji (an ultrasound-guided HIFU therapy system) Experimental Treatment 4 Interventions

Suizenji (an ultrasound-guided HIFU therapy system)

Who Is Running the Clinical Trial?

SONIRE Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

90+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07033689

Feasibility Study of Suizenji, in Patients With Unresectable ... Device Suizenji (an ultrasound-guided HIFU therapy system) HIFU Treatment Treatment will sonicate at least 50% of the tumor volume. Safety margins between the ...

2. fusfoundation.org fusfoundation.org/posts/fda-grants-breakthrough-device-designation-for-pancreatic-cancer-treatment/

FDA Grants Breakthrough Device Designation for ... SONIRE's Suizenji system was developed based on a device used in a clinical study for pancreatic cancer in Japan in 2017. It uses cavitation ...

3. npcf.us npcf.us/clinical-trials/feasibility-study-of-suizenji-in-patients-with-unresectable-pancreatic-ductal-adenocarcinoma-sunrise-ii/

Feasibility Study Of Suizenji, In Patients With Unresectable ... The targeted area is then heated, which kills the pancreatic cancer cells, and as a result, the patient's life may be prolonged. Experience with Suizenji for ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05601323

A Study of Suizenji in Patients With Unresectable ... 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37641497/

Analysis of the results of high-intensity focused ultrasound ... Conclusion: HIFU is safe and effective for pancreatic cancer treatment, and has the potential to become an important supplement for the treatment of ...

6. withpower.com withpower.com/trial/early-phase-1-pancreatic-neoplasms-11-2025-3774a

Suizenji for Pancreatic Cancer · Info for Participants This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity ...