臨床研究等提出・公開システム

Cryoablation using the CryoBalloon Ablation System (CBAS) for superficial esophageal squamous cell carcinoma on or near the scar after endoscopic treatment: Efficacy and safety study

CRYO-SCAR study

15

15 patients with 17 lesions were screened and enrolled, all of whom completed the treatment protocol. The median (min-max) age of 15 patients in Full Analysis Set (FAS) was 74 (60-80) years. Sex was male in 14 patients (93.3%) and female in 1 patient (6.7%) Performance status was "0" in 15 patients (100%) .

Signed informed consent: 15 patients Registered: 15 patients, Completed study treatment: 15 patients Discontinued from the study: none

No serious AEs, such as perforation, bleeding, or death, were reported during the study period. Notably, no treatment-related AEs of grade 3 or higher were recorded. Among the observed AEs, one patient experienced grade 2 esophageal pain, two patients had grade 1 esophageal stricture, and one patient reported vomiting. A Grade 3 biliary tract infection was observed as treatment-unrelated AE due to suspected presence of stones in the common bile duct. Regarding pain, the study observed a maximum NRS score of 3, and almost all patients experienced pain resolution by day 7, with only one exception. Furthermore, all the patients reported being pain-free by day 28.

In 15 patients, the main lesions were assessed for L-CR 48 weeks after the first cryoablation, with an L-CR rate of 100% ( 90% confidence interval [CI], 81.9% -100%)

All 17 lesions achieved L-CR 48 weeks after the first cryoablation, with an L-CR rate of 100% (95% CI, 80.5% -100%). Relapse-free survival and Overall survival are during the median follow-up period of 14.3 (IQR, 11.7 - 14.5) months, no recurrences or deaths occurred.

the CBAS demonstrated as a potential treatment for SESCC on the post-ER scar, which was confirmed to be intramucosal through endoscopic diagnosis.

Feb. 29, 2024

https://www.sciencedirect.com/science/article/pii/S0016510724001342?via%3Dihub

No

National Cancer Center Hospital East

6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan

CRYO-SCAR_core@east.ncc.go.jp

National Cancer Center Hospital East

6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan

+81-4-7133-1111

CRYO-SCAR_core@east.ncc.go.jp

completed

Nov. 01, 2020

Interventional

non-blinded, single-arm, pivotal study

treatment purpose

N/A

Eligibility criteria include, but are not limited to, the following:
1) Patients from whom written consent to participate in the study is obtained.
2) Patients aged greater than 20 years at the time of consent obtaining.
3) Patients with esophageal cancer who have been histologically diagnosed with squamous cell carcinoma.
4)Patients whose lesions are diagnosed on or near the scar after endoscopy treatment, whose lesions depth is within the mucosa, and for whose lesions ESD/EMR is technically difficult.
5) Patients having a lesion within thoracic or abdominal esophagus
6) Patients showing neither lymph node metastasis nor distant metastasis in image by CT at screening.
7) Patients who can pass through a therapeutic endoscope.
8) Patients with an ECOG Performance Status (PS) of 0 to 2 at the time of enrollment.
9) Patients who are judged to have enough organ functions based on laboratory values measured within 28 days before enrollment.
10) Patients who can follow up 12 months after primary cryoablation.
11) Women of childbearing potential who are negative in a urine pregnancy test agree to use contraception from obtaining informed consent through 6 months after the Cryoablation.

Exclusion criteria including below but not limited to:
1) Diameter of lesion >50mm
2) Circumferential extent of target lesion is 360 degrees.
3) Patients whom a lesion targeted for treatment has more than 4 lesions
4) Patients whose Cryoablation treatment area is expected to cover the entire circumference.
5) Patients who has active multiple primary cancer.
6) Target tissue varices at risk for bleeding
7) Prior Heller myotomy
8) Patients who has serious complications such as Unstable angina, uncontrolled blood pressure, serious heart disease.
9) Patients with respiratory disease requiring oxygen administration.
10) Patients having serious complications
11) Pregnant or breastfeeding female patients.
12) Patients who are judged by the principal investigator as ineligible to be administered the Cryoablation, or in whom the principal investigator judges that treatment cannot be performed safely.

Both

esophageal cancer

investigational material(s)
Generic name etc : Cryosurgical unit
INN of investigational material :
Therapeutic category code :
Dosage and Administration for Investigational material : The lesions are identified under endoscopic observation and cryoablation is performed to cover the lesions.

control material(s)
Generic name etc : -
INN of investigational material :
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
Rate of local complete response (L-CR) judged in an independent committee after 48 weeks from the Cryoablation.

efficacy
safety
other
1) Rate of local complete response (L-CR) judged the principal investigator or sub-investigator after 48 weeks from the Cryoablation.
2) Rate of L-CR for all lesions
3) Rate of technically successful ablation
4) Treatment time of the Cryoablation
5) Pain score after the treatment
6) Recurrence free survival
7) Overall survival
8) Incidence rate of adverse event

+81-4-7133-1111

April. 15, 2020