RecruitingPhase 3NCT05798793

Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma

A Multi-Center, Randomized Phase III Study of Neoadjuvant Anti-PD-1 Immunotherapy Plus TP Chemotherapy Versus TP Chemotherapy or Up-Front Surgery in Resectable Locally Advanced Oral Squamous Cell Carcinoma


Sponsor

Hospital of Stomatology, Wuhan University

Enrollment

309 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate the survival benefit of neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy compared with TP chemotherapy or up-front surgery in resectable locally advanced oral squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immunotherapy (an anti-PD-1 drug) and chemotherapy given before surgery (called neoadjuvant treatment) in patients with locally advanced oral cavity squamous cell carcinoma — a type of mouth cancer — to shrink the tumor before removal. **You may be eligible if...** - You have been diagnosed with oral squamous cell carcinoma (mouth cancer) confirmed by biopsy - Your cancer is locally advanced (stage T1-2N1-2M0 or T3-4aN0-2M0) and is potentially curable by surgery - There is no evidence of spread to distant parts of the body - Your blood counts, liver function, and other organ measurements meet required levels **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have poor organ function - Other health or prior treatment criteria apply 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

DRUGCamrelizumab plus TP

The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.

DRUGTP

The participants will receive docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.


Locations(3)

Peking university Shenzhen hospital

Shenzhen, Guangdong, China

Hospital of Stomatology, Wuhan University

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

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NCT05798793


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