RecruitingPhase 3NCT06258811

Neoadjuvant Immunochemotherapy for LAOSCC

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


Sponsor

Lai-ping Zhong

Enrollment

134 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach called neoadjuvant immunochemotherapy — combining immunotherapy and chemotherapy before surgery — for people with locally advanced oral cavity cancer (cancer in the mouth). The goal is to shrink the cancer before removal to improve surgical outcomes. **You may be eligible if...** - You have a confirmed diagnosis of squamous cell carcinoma of the oral cavity (tongue, gums, cheek, floor of mouth, hard palate, or molar area) - Your cancer is Stage III or IVA (locally advanced but not yet spread to distant organs) - You are in good physical condition (ECOG score 0 or 1) - You have at least one measurable tumor on imaging - Your blood counts, liver, kidney, and clotting function meet minimum requirements **You may NOT be eligible if...** - You have a known allergy to any components of the treatment - You have a history of another cancer in the past 5 years (unless cured) - You have previously had radiation to the head and neck - You are receiving another immunotherapy treatment - You are pregnant or breastfeeding - You have active hepatitis B or C, or significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGalbumin 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

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NCT06258811


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