Role of Porcine Fibrin Sealant in the Prevention of Cervical Anastomotic Leakage After Esophagectomy for Esophageal or Esophagogastric Junction Cancer (PLACE020): A Phase 2, Single-Arm, Prospective Study

2019 ◽  
Author(s):  
Yaobin Lin ◽  
Yihuai Hu ◽  
Yan Huang ◽  
Kongjia Luo ◽  
Kexi Wang ◽  
...  
Keyword(s):  
Prospective Study ◽  
Anastomotic Leakage ◽  
Fibrin Sealant ◽  
Esophagogastric Junction ◽  
Phase 2 ◽  
Esophagogastric Junction Cancer

scholarly journals An Investigator-Initiated Phase 2 Study of Nivolumab Plus Low-Dose Ipilimumab as First-Line Therapy for Microsatellite Instability—High Advanced Gastric or Esophagogastric Junction Cancer (NO LIMIT, WJOG13320G/CA209-7W7)

Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 805
Author(s):  
Hisato Kawakami ◽  
Shuichi Hironaka ◽  
Taito Esaki ◽  
Kazuaki Chayama ◽  
Masahiro Tsuda ◽  
...  
Keyword(s):  
Microsatellite Instability ◽  
Esophagogastric Junction ◽  
Low Dose ◽  
Group Performance ◽  
Survival Duration ◽  
Phase 2 ◽  
First Line ◽  
Number Of Patients ◽  
Esophagogastric Junction Cancer ◽  
Line Setting

Nivolumab (NIVO) plus low-dose ipilimumab (IPI) has shown a promising survival benefit in first-line treatment of microsatellite instability-high (MSI-H) colorectal cancer. We hypothesized that this regimen might also be beneficial for MSI-H gastric cancer (GC), which accounts for ~5% of all GC cases. NO LIMIT (WJOG13320G/CA209-7W7) is an investigator-initiated, single-arm, open-label, 14-center phase 2 trial of NIVO plus low-dose IPI for MSI-H GC in the first-line setting. Eligibility criteria include unresectable advanced, recurrent, or metastatic gastric or esophagogastric junction cancer with a histologically confirmed diagnosis of adenocarcinoma; confirmed MSI-H status with the MSI-IVD Kit (FALCO); no prior systemic anticancer therapy; an Eastern Cooperative Oncology Group performance status of 0 or 1; and a measurable lesion per RECIST 1.1. The primary objective of the study is to determine the overall response rate (ORR) for the NIVO+IPI regimen as assessed by blinded independent central review. Secondary end points include progression-free survival, overall survival, duration of response, safety, tolerability, and biomarkers. The number of patients was set at 28 on the basis of the threshold and expected ORR values of 35 and 65%, respectively, with a one-sided alpha error of 0.025 and power of 0.80. Subjects will receive treatment with nivolumab (240 mg) biweekly in combination with ipilimumab (1 mg/kg) every 6 weeks. The results of this study should clarify the therapeutic potential of NIVO+IPI for MSI-H GC in the first-line setting. Trial registration: JapicCTI-205400.

Role of Pro-inflammatory biomarkers in Hashimoto's thyroiditis: A prospective study

2018 ◽  
Author(s):  
B Ramesh ◽  
B Rajesh ◽  
Reddy B Rajkiran ◽  
G Gayathri ◽  
Reddy M Venkateshwara ◽  
...  
Keyword(s):  
Prospective Study ◽  
Hashimoto’S Thyroiditis ◽  
Inflammatory Biomarkers ◽  
Hashimoto's Thyroiditis ◽  
A Prospective Study

A prospective study of the role of coxsackie B and other enterovirus infections in the pathogenesis of IDDM. Childhood Diabetes in Finland (DiMe) Study Group

Diabetes ◽  
1995 ◽  
Vol 44 (6) ◽  
pp. 652-657 ◽  
Author(s):  
H. Hyoty ◽  
M. Hiltunen ◽  
M. Knip ◽  
M. Laakkonen ◽  
P. Vahasalo ◽  
...  
Keyword(s):  
Prospective Study ◽  
Study Group ◽  
Childhood Diabetes ◽  
A Prospective Study ◽  
Coxsackie B

The role of blood inflammatory markers in the diagnosis of appendicitis in children: a prospective study from a University Hospital in Greece

2020 ◽  
Vol 178 (11) ◽  
Author(s):  
George Sakellaris ◽  
Dimitra Dimopoulou ◽  
Maria Niniraki ◽  
Anastasia Dimopoulou ◽  
Athanasios Alegakis ◽  
...  
Keyword(s):  
Prospective Study ◽  
Inflammatory Markers ◽  
University Hospital ◽  
A Prospective Study
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