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Trial Title:
SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx
NCT ID:
NCT06219980
Condition:
SBRT
Conditions: Official terms:
Carcinoma, Squamous Cell
Conditions: Keywords:
SBRT
immunotherapy
oral cancer
oropharyngeal cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
SBRT+chemoimmunotherapy
Description:
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.
Arm group label:
treatment group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Fang-Yun Xie, professor
Phone:
+86-20-87342926
Email:
xiefy@sysucc.org.cn
Start date:
December 7, 2023
Completion date:
December 7, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06219980
