Guilhérand-granges, France
A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
Phase
2Span
312 weeksSponsor
GlaxoSmithKlineFukuoka
Recruiting
Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
Phase
1Span
252 weeksSponsor
Kyushu UniversityFukuoka
Recruiting
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
Phase
3Span
188 weeksSponsor
ChimerixFukuoka
Recruiting
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Phase
3Span
209 weeksSponsor
Hoffmann-La RocheFukuoka
Recruiting
TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer
Total neoadjuvant therapy (TNT) for locally advanced rectal cancer (LARC) has the promise, which means non-operative management (NOM) enable more patients (pts) with a complete clinical response (cCR) or near-complete clinical responses (nCR) after TNT to avoid subsequent radical surgery, with potentially maintaining anorectal function and quality of life (QoL). Recently, PRODIGE-23 trial demonstrated that triplet regimen (Irinotecan, oxaliplatin and fluoropyrimidine) before preoperative chemoradiotherapy (CRT) significantly improved outcomes compared with CRT. However, there has been no prospective study comparing consolidation triplet with doublet regimens following short course radiotherapy (SCRT). The aim of this randomized phase III trial is to test superiority of consolidation irinotecan, capecitabine and oxaliplatin (CAPOXIRI) vs. capecitabine and oxaliplatin (CAPOX) following SCRT as TNT in pts with LARC. Pts in both groups will be re-staged after completing TNT before radical surgery according to the Memorial Sloan Kettering Regression Schema; pts with incomplete response (iCR) will undergo total mesorectal excision (TME), cCR pts will receive NOM, and nCR pts will undergo TME or NOM by a physician discretion under the recommendation of blind assessment by the designated NOM central committee. Pts will be followed by CT, MRI, colonoscopy and liquid biopsy every 4 months for 2 years, and every 6 months thereafter up to 5 years. To detect a decrease in 3-year cumulative probability of organ preservation-adapted Disease free survival (DFS) from 75.0% to 81.7%, corresponding to a target hazard ratio of 0·70, a total of 608 pts (196 events) would achieve 70% power at a two-sided α significance level of 0.05.
Phase
3Span
424 weeksSponsor
National Cancer Center Hospital EastFukuoka
Recruiting
Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)
Phase
3Span
290 weeksSponsor
Merck Sharp & Dohme LLCFukuoka
Recruiting
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products
Phase
N/ASpan
251 weeksSponsor
Hoffmann-La RocheFukuoka
Recruiting
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
Phase
3Span
162 weeksSponsor
Immunovant Sciences GmbHFukuoka
Recruiting
Fukuoka
Recruiting
An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Phase
3Span
210 weeksSponsor
Karuna TherapeuticsFukuoka
Recruiting