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A Prospective, Single-arm Phase II Clinical Trial of Tislelizumab Combined With Platinum Doublet Neoadjuvant Therapy to Improve Mandibular Preservation in Resectable Locally Advanced Oral Squamous Cell Carcinoma. — B2023-153  

Oral Squamous Cell Carcinoma Clinical Trial

Official title:
替雷利珠单抗联合含铂双药新辅助治疗用于提高可切除局部晚期口腔鳞癌下颌骨保留的前瞻性、单臂Ⅱ期临床试验

Clinical Trial Summary

Given the feasibility of induction chemotherapy in oral cancer and the encouraging remission rates achieved, we explore the clinical application prospects of using tislelizumab in combination with traditional standard chemotherapy as induction treatment in oral cancer patients who have no radiological evidence of mandibular erosion but require mandibulectomy due to the tumor's proximity to the mandible, aiming to shrink tumor size and increase the rate of mandible preservation. Therefore, we propose to conduct a prospective, single-arm, single-center phase II exploratory clinical trial: we plan to select patients with locally advanced resectable primary oral squamous cell carcinoma T3-4N0-3M0 (stages III-IVb, excluding T1-2) after multidisciplinary consultation and assessment by imaging and clinical evaluation. We aim to explore the feasibility of a three-week treatment regimen combining tislelizumab with polyaletin paclitaxel and a platinum-based triplet, preliminarily assess its clinical efficacy, adverse reactions, and postoperative mandible preservation rate, to provide the best comprehensive treatment plan for the preservation rate of the mandible in oral squamous cell carcinoma.

Clinical Trial Description

In this study, eligible subject will be enrolled into study arm to accept study treatment mandibular Preservation Rate will be the primary outcome measures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06130007
Study type Interventional
Source Sun Yat-sen University
Contact Qi Fang Fang, MD
Phone 8613856534831
Email fangqi@sysucc.org.cn
Status Not yet recruiting
Phase Phase 2
Start date November 25, 2023
Completion date October 25, 2024
View Details
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