Actively Recruiting
SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx
Led by Sun Yat-sen University · Updated on 2024-03-12
25
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed squamous carcinoma of oral cavity or oropharynx
- Stage III-IVa based on the eighth edition of AJCC
- Aged 18 to 70 years
- ECOG performance status 0-1
- No organ dysfunction
- Expected survival of at least 3 months
You will not qualify if you...
- Diagnosed with other malignant tumors
- Have autoimmune diseases or serious mental illness
- At high risk of hemorrhage
- Received systemic or local glucocorticoid therapy within 4 weeks
- Require long-term treatment with immunosuppressive drugs or corticosteroids in immunosuppressive doses
- Active tuberculosis currently treated or treated within 1 year before screening
- Prior use of anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies
- HIV or HCV infection
- Positive HBsAg with HBV DNA copy number 61000 cps/ml
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
F
Fang-Yun Xie
CONTACT
X
Xue-Kui Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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