SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx

SBRT Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219980
• Other study ID #: B2023-278-01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 7, 2023
• Est. completion date: December 7, 2026

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: Fang-Yun Xie
• Phone: +862087342926
• Email: xiefy[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 7, 2026
• Est. primary completion date: December 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• SBRT

Intervention

Combination Product:
• SBRT+chemoimmunotherapy
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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Erratum In: Nat Cancer. 2023 Jan;4(1):148. Nat Cancer. 2024 Jan;5(1):210. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of pathological complete response	pathological complete response rate after radical resection	immediately after the surgery
Secondary	rate of major pathological response		immediately after the surgery
Secondary	objective response rate		two weeks after the chemoimmunotherapy
Secondary	disease free survival		3-year
Secondary	overall survival		3-year
Secondary	rate of adverse events		one month after the postoperative radiotherapy