Combining targeted radiation with immunotherapy for advanced oral and throat cancer
Official title: 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
Run by Sun Yat-sen University · NCT06219980 · Data updated 2026-11-12
This study is testing a new treatment that combines targeted radiation with immunotherapy to see if it helps people with advanced oral and throat cancer before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Sindilizumab, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | December 7, 2023 |
| Main results expected | December 7, 2025 |
| Study ends | December 7, 2026 |
| Registry record updated | March 12, 2024 |
| Trial ID | NCT06219980 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 70 with pathologically confirmed squamous carcinoma of the oral cavity or oropharynx at stages III-IVa.
✕Probably not a fit
Patients with other malignant tumors, autoimmune diseases, or those requiring immunosuppressive therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of stereotactic body radiation therapy (SBRT) followed by neoadjuvant chemoimmunotherapy using Sindilizumab, docetaxel, and cisplatin in patients with resectable locally advanced squamous carcinoma of the oral cavity and oropharynx. The treatment involves delivering a total dose of 18 Gy of SBRT to the tumor and affected lymph nodes, followed by a regimen of chemoimmunotherapy administered every three weeks for three cycles. The primary goal is to evaluate the pathological complete response rate and the safety of this combined treatment approach before surgical resection and potential postoperative therapies.
Why it matters
Potential benefit: If successful, this treatment could improve the effectiveness of therapy for patients with advanced oral and throat cancers, potentially leading to better survival rates.
How similar studies have gone: While the combination of SBRT and immunotherapy is a novel approach, similar studies have shown promise in treating other cancers, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Fang-Yun Xie
- Email: xiefy@sysucc.org.cn
- Phone: +862087342926
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.