NCT06219980RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 4 Jan 2024
- Start date
- 7 Dec 2023
- Primary completion date
- 7 Dec 2025
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Head and neck cancer
- NCT number
- NCT06219980
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 7 Dec 2023 to the primary completion date, 7 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- diagnosed with other malignant tumors
- has autoimmune diseases or serious mental illness
- at high risk of hemorrhage
- HIV or HCV
- HBsAg positive with positive HBV DNA copy number (quantitative test) ≥1000cps/ml
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.