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Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)

StatusRecruiting
PhasePhase 3
Started2022-10-28
View on ClinicalTrials.gov ↗

Amendment history

2024-05-16
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v3
Study sites1→3
Collaborators+78 characters
Zhongshan People's Hospital, Guangdong, China Shenzhen Sixth People's Hospital
2024-03-24
Study Status, Study Design, Arms and Interventions v2
Enrollment target588→537
InterventionsCisplatin （neoadjuvant） (Drug), Cisplatin（adjuvant） (Drug), Nab-paclitaxel （neoadjuvant） (Drug), Radiation (Radiation), Surgical resection…→Carboplatin (adjuvant） (Drug), Carboplatin (neoadjuvant） (Drug), Cisplatin （neoadjuvant） (Drug), Cisplatin（adjuvant） (Drug), Nab-paclitaxel…
2022-10-28
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-10→confirmed 2022-10-28
Study sites0→1
2022-10-14
Original filing
A prospective, randomized, open-label, multicenter Phase 3 trial designed to compare the safety and efficacy of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable head and neck squamous cell carcinoma.
Trial Details
NCT Number NCT05582265
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators: Zhongshan People's Hospital, Guangdong, China, Shenzhen Sixth People's Hospital
Conditions Head and Neck Squamous Cell Carcinomas
Enrollment 537 participants
Start Date 2022-10-28
Primary Completion 2028-10 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2024-05-17