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

NCT06219980 | Recruiting Phase 2

• 1 other identifier: B2023-278-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

SBRT

Keywords

SBRT; immunotherapy; oral cancer; oropharyngeal cancer

Outcome Measures

Primary Outcomes (1)

• rate of pathological complete response

  pathological complete response rate after radical resection

  immediately after the surgery

Secondary Outcomes (5)

• rate of major pathological response

  immediately after the surgery

• objective response rate

  two weeks after the chemoimmunotherapy

• disease free survival

  3-year

• overall survival

  3-year

• rate of adverse events

  one month after the postoperative radiotherapy

Study Arms (1)

treatment group

EXPERIMENTAL

Combination Product: SBRT+chemoimmunotherapy

Interventions

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.

treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related 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.

  PMID: 36434392 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.

  PMID: 37141981 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Fang-Yun Xie

CONTACT

+862087342926; xiefy@sysucc.org.cn

Xue-Kui Liu

CONTACT

liuxk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 23, 2024
• Study Start: December 7, 2023
• Primary Completion: December 7, 2025
• Study Completion (Estimated): December 7, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)