Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SBRT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT+chemoimmunotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- interventionNames
- Combination Product: SBRT+chemoimmunotherapy
Primary outcomes (1)
- measure
- rate of pathological complete response
- timeFrame
- immediately after the surgery
- description
- pathological complete response rate after radical resection
Secondary outcomes (5)
- measure
- rate of major pathological response
- timeFrame
- immediately after the surgery
- measure
- objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDDarragh LB, Knitz MM, Hu J, Clambey ET, Backus J, Dumit A, Samedi V, Bubak A, Greene C, Waxweiler T, Mehrotra S, Bhatia S, Gadwa J, Bickett T, Piper M, Fakhoury K, Liu A, Petit J, Bowles D, Thaker A, Atiyeh K, Goddard J, Hoyer R, Van Bokhoven A, Jordan K, Jimeno A, D'Alessandro A, Raben D, McDermott JD, Karam SD. A phase I/Ib trial and biological correlate analysis of neoadjuvant SBRT with single-dose durvalumab in HPV-unrelated locally advanced HNSCC. Nat Cancer. 2022 Nov;3(11):1300-1317. doi: 10.1038/s43018-022-00450-6. Epub 2022 Nov 25. PMID 36434392
- BACKGROUNDMa TM, Wong DJ, Chai-Ho W, Mendelsohn A, St John M, Abemayor E, Chhetri D, Sajed D, Dang A, Chu FI, Xiang M, Savjanji R, Weidhaas J, Steinberg ML, Cao M, Kishan AU, Chin RK. High Recurrence for HPV-Positive Oropharyngeal Cancer With Neoadjuvant Radiation Therapy to Gross Disease Plus Immunotherapy: Analysis From a Prospective Phase Ib/II Clinical Trial. Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):348-354. doi: 10.1016/j.ijrobp.2023.04.029. Epub 2023 May 2. No abstract available. PMID 37141981