NCT06130007

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.

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Xuekui Liu · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Oral Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy	Three-Week Treatment Regimen with Trastuzumab in Combination with Docetaxel and Platinum Triple Therapy

Timeline

• Start date: 2023-11-25
• Primary completion: 2024-09-25
• Completion: 2024-10-25
• First posted: 2023-11-13
• Last updated: 2023-11-13