Clinical trial NCT06219980: SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: SBRT
Keywords: SBRT
immunotherapy
oral cancer
oropharyngeal cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: rate of pathological complete response
timeFrame: immediately after the surgery
Secondary outcomes:
measure: rate of major pathological response
timeFrame: immediately after the surgery
measure: objective response rate
timeFrame: two weeks after the chemoimmunotherapy
measure: disease free survival
timeFrame: 3-year
measure: overall survival
timeFrame: 3-year
measure: rate of adverse events
timeFrame: one month after the postoperative radiotherapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
citation: 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.
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.