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RECRUITING
NCT05862168
PHASE2

Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective, Phase II Trial

Sponsor: Weijia Fang, MD

View on ClinicalTrials.gov

Summary

TPF is still recommended as the preferred induction chemotherapy regimen for nonsurgical treatment of patients with LA HNSCC. Based on the KEYNOTE-048 study, all major guidelines recommend PD-1 monotherapy or PD-1 combined with chemotherapy as the new first-line standard treatment for patients with advanced HNSCC. The immunotherapy in operable LA HNSCC was also explored as neoadjuvant therapy due to the excellent data in advanced HNSCC. These explorations have also achieved good results. Therefore, this study aims to explore the pathological remission rate, the long-term benefit and safety of Tislelizumab combined with albumin paclitaxel, cisplatin and fluorouracil for locally advanced oral squamous cell carcinoma.

Official title: Neoadjuvant Tislelizumab Combined With Albumin-paclitaxel, Cisplatin, and Fluorouracil in Patients With Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective,Phase II Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-05-08

Completion Date

2028-06-30

Last Updated

2023-07-17

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab

The participants will receive 3 cycles of Tislelizumab, with 21 days each. 200mg of Tislelizumab will be used intravenously on the first day of each cycle.

DRUG

Albumin paclitaxel

The participants will receive 3 cycles of Albumin paclitaxel, with 21 days each. 200mg/m\^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.

DRUG

Cisplatin

The participants will receive 3 cycles of Cisplatin, with 21 days each. 20mg/m\^2 of Cisplatin will be used intravenously on days 1 through 3 of each cycle.

DRUG

5-Fluorouracil

The participants will receive 3 cycles of 5-Fluorouracil, with 21 days each. 600mg/m\^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.

Locations (1)

First affiliated hospital, School of Medicine, Zhejiang University

Hangzhou, China