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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT+chemoimmunotherapy | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| rate of pathological complete response | pathological complete response rate after radical resection | immediately after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| rate of major pathological response | immediately after the surgery | |
| objective response rate | two weeks after the chemoimmunotherapy | |
| disease free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang-Yun Xie | Contact | +862087342926 | xiefy@sysucc.org.cn | |
| Xue-Kui Liu | Contact | liuxk@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36434392 | Background | Darragh 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. | |
| 37141981 |
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|
| 3-year |
| overall survival | 3-year |
| rate of adverse events | one month after the postoperative radiotherapy |
| Background |
| Ma 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. |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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