RecruitingPhase 2NCT06219980

SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx

A Phase II Study of SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx


Sponsor

Sun Yat-sen University

Enrollment

25 participants

Start Date

Dec 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

In resectable locally advanced oral cavity cancer and oropharyngeal cancer, SBRT with the total dose of 18 Gy by three fractions will be delivered to the primary tumor and metastatic lymph nodes every other day. One week later, neoadjuvant chemoimmunotherapy of Sindilizumab (200mg) plus docetaxel (75mg/m2) and cisplatin (75mg/m2) will be administered every three weeks for three cycles. Then radical surgical resection will be performed and postoperative radiotherapy with or without chemotherapy will be supplemented according to the initial tumor staging and postoperative pathologic characteristics. The investigators aim to evaluate the pathological complete response rate and safety of the combined treatment of SBRT with chemoimmunotherapy in locally advanced cancers of oral cavity and oropharynx.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination treatment for locally advanced mouth and throat (oral cavity and oropharyngeal) squamous cell cancers. The approach combines stereotactic body radiation therapy (SBRT), an immunotherapy drug (sintilimab), and two chemotherapy drugs (docetaxel and cisplatin) given before surgery, to shrink the tumor and improve surgical outcomes. **You may be eligible if...** - You are aged 18–70 with a pathologically confirmed squamous cell carcinoma of the oral cavity or oropharynx - Your cancer is locally advanced (Stage III–IVa per AJCC 8th edition) - You have no other organ dysfunction and are in adequate overall health (ECOG 0–1) **You may NOT be eligible if...** - You have another active cancer - You have autoimmune disease or a serious mental illness - You are at high risk of bleeding - You have received prior anti-PD-1/PD-L1 immunotherapy - You have active HIV, hepatitis C, or high-level hepatitis B infection - You used systemic steroids in the past 4 weeks 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

COMBINATION_PRODUCTSBRT+chemoimmunotherapy

All eligible patients will receive SBRT (6Gy\*3 fractions, qod) to the primary site and metastatic lymph nodes. One week later, neoadjuvant chemoimmunotherapy of Sindilizumab (200mg) plus docetaxel (75mg/m2) and cisplatin (75mg/m2) will be administered every three weeks for three cycles. Then radical surgical resection will be performed and postoperative radiotherapy with or without chemotherapy will be supplemented according to the initial tumor staging and postoperative pathologic characteristics.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06219980


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