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RECRUITING
NCT06258811
PHASE3

Neoadjuvant Immunochemotherapy for LAOSCC

Sponsor: Lai-ping Zhong

View on ClinicalTrials.gov

Summary

To evaluate the prognostic efficacy of neoadjuvant immunochemotherapy with tislelizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy compared with standard therapy for patients with locally advanced and resectable oral squamous cell carcinoma.

Official title: Neoadjuvant Immunochemotherapy With Tislelizumab, Albumin Paclitaxel and Cisplatin Followed by Standard Therapy Versus Standard Therapy for Locally Advanced Oral Squamous Cell Carcinoma, a Multicenter Randomized Phase 3 Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2024-02-20

Completion Date

2028-12-30

Last Updated

2025-03-13

Healthy Volunteers

No

Interventions

DRUG

albumin paclitaxel, cispatin, tislelizumab

Neoadjuvant immunochemotherapy (2 cycles, and 21 days each cycle, 260mg/m2 albumin paclitaxel intravenously on day 1 and day 22, with 75mg/m2 of cisplatin and 200mg of tislelizumab) + radical surgery + adjuvant therapy (radiation/chemoradiation followed by 200mg of tislelizumab, every 3 weeks for one year)

Locations (1)

Huashan Hospital, Fudan University

Shanghai, China