Feasibility Study of Suizenji, in Patients With Unresectable Pancreatic Ductal Adenocarcinoma (SUNRISE-II)

Part of paid clinical trials in San Francisco, California.

Sponsor: SONIRE Therapeutics Inc.
Study ID: NCT07033689
Phase: EARLY_PHASE1
Status: Recruiting

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Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Suizenji (an ultrasound-guided HIFU therapy system) — DEVICE
Suizenji (an ultrasound-guided HIFU therapy system)
Nal-IRI/FL — DRUG
Standard of care
mFOLFIRINOX adjuvant chemotherapy — DRUG
standard of care
Gem/nab-PTX — DRUG
standard of care

Study Details

This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system for the treatment of unresectable pancreatic ductal adenocarcinoma. Focused ultrasound therapy uses a number of small ultrasound generators attached to a bowl-shaped ultrasound generator to emit ultrasound waves from outside to inside the body and focus them on a single point where cancerous cells in the pancreas are located. 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 pancreatic cancer patients has shown that the "heating" is only a warm feeling in the abdomen during the treatment.