Status:
RECRUITING
SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx
Lead Sponsor:
Sun Yat-sen University
Conditions:
SBRT
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- pathologically confirmed squamous carcinoma of oral cavity or oropharynx
- III-IVa based on the eighth edition of AJCC
- aged 18 to 70
- ECOG PS 0-1
- no organ dysfunction
- Expected survival ≥ 3 months
Exclusion
- diagnosed with other malignant tumors
- has autoimmune diseases or serious mental illness
- at high risk of hemorrhage
- Systemic or local glucocorticoid therapy within 4 weeks
- Comorbidities requiring long-term treatment with immunosuppressive drugs or systemic or topical corticosteroids in immunosuppressive doses
- Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.
- Prior use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody
- HIV or HCV
- HBsAg positive with positive HBV DNA copy number (quantitative test) ≥1000cps/ml
Key Trial Info
Start Date :
December 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 7 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06219980
Start Date
December 7 2023
End Date
December 7 2026
Last Update
March 12 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060