Evaluation of therapeutic efficacy and safety of concurrent FOLFIRINOX plus high intensity focused ultrasound (ALPIUS 900) for locally advanced/borderline resectable pancreatic cancer: A prospective single-center, single-arm, investigator-initiated, open-labeled, exploratory clinical trial

Seoul National University Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年7月12日

适应症

试验速览

暂无简介。

•1.Adults over 19–85
•2.Persons with a Karnofsky Performance Scale (KPS) of 70 percent or more;
•3.A person diagnosed as a tubular adenocarcinoma through biopsy.
•4.A person diagnosed with LAPC/BRPC by computed tomography (CT) or magnetic resonance imaging (MRI)
•- Diagnosis results based on CT or MRI taken at the hospital where pancreatic cancer was first diagnosed or being treated are recognized as valid. However, only the results obtained within 4 weeks from the screening date are accepted.
•- LAPC/BRPC is determined by investigators based on the American Point Committee on Cancer (AJCC) guidelines (see table below).
•T1 Tumor diameter < 2cm
•T22cm = tumor diameter = 4cm
•T3Tumor diameter > 4cm
•T4Invasion of the celiac trunk, the superior mesenteric artery, and proper hepatic artery, regardless of tumor size.
•N0No LN metastasis
•N1Regional LN metastasis 1~3
•N2Regional LN metastasis 4 or more
•M0 No distant metastasis
•M1 Distant metastasis
•- Cases with distant metastasis are excluded; LAPC indicates T4NxM0; and BRPC indicates when T4 is not clear with NxM0.
•5.A person willing to voluntarily agree to a clinical trial and comply with the test plan

•1. The presence of a cystic lesion within pancreatic cancer to be treated with HIFU or at the pancreas adjacent to the pancreatic cancer.
•2. The presence of a wide range of scar or surgical clips observed in the passage through the ultrasonic beam.
•3. In case proper ultrasound images for HIFU procedures are not shown
•4. A person who cannot lie down in a comfortable position.
•5. A person who has difficulty communicating
•6. A person who has experience in toxic or hypersensitive reactions to FOLFIRINOX anticancer drugs.
•7. A person pregnant or breastfeeding
•8. Pancreatic cancer patients who have previously been anti-cancer treatment
•9. If severe side effects such as aortic rupture, duodenum perforation, gastrointestinal damage or intestinal necrosis are expected due to HIFU procedures.
•10. Other cases where participation in this clinical trial is judged inappropriate by the investigator (specific reasons should be recorded in the case report form)

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