Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC

Recruiting Phase 3 Interventional Study
Head and Neck Squamous Cell Carcinoma Neoadjuvant Therapy Pembrolizumab
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
272 (estimated)
Sponsor
Beijing Tongren Hospital · Other
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About This Trial
This study is a prospective, open-label, multi-center phase III study; patients with untreated stage IIIA to stage IVB head and neck squamous cell carcinoma (including oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer) who meet the inclusion criteria are randomized 1:1 and given pembrolizumab 200 mg d1+ chemotherapy for 2 cycles (experimental group), 2 cycles of…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients with stage IIIA-IVB head and neck squamous cell carcinoma confirmed by histology and/or cytology; 2. Have not received immunotherapy in the past; 3. The researchers believe that he can safely receive pembrolizumab combined with chemotherapy or neoadjuvant chemotherap…
Contacts

Zhigang Huang

+86 13701208337

huangzhigang1963@sohu.com

CONTACT

Yang Zhang

+86 13311365369

Zhangyangent@163.com

CONTACT