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NCT Number: NCT06219980

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

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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Key information

Conditions

SBRT Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Fang-Yun Xie, professor

CONTACT

[email protected]

+86-20-87342926

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. rate of pathological complete response

    Time frame: immediately after the surgery

    pathological complete response rate after radical resection

Secondary outcomes

  1. rate of major pathological response

    Time frame: immediately after the surgery

  2. objective response rate

    Time frame: two weeks after the chemoimmunotherapy

  3. disease free survival

    Time frame: 3-year

  4. overall survival

    Time frame: 3-year

  5. rate of adverse events

    Time frame: one month after the postoperative radiotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Fang-Yun Xie

CONTACT

[email protected]

+862087342926

Xue-Kui Liu

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 23, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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