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

Last updated: March 8, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Lung Cancer

Treatment

SBRT+chemoimmunotherapy

Clinical Study ID

NCT06219980
B2023-278-01
  • Ages 18-70
  • All Genders

Study 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

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

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 systemicor topical corticosteroids in immunosuppressive doses
  • Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatmentor 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, oranti-CTLA-4 antibody
  • HIV or HCV
  • HBsAg positive with positive HBV DNA copy number (quantitative test) ≥1000cps/ml

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: SBRT+chemoimmunotherapy
Phase: 2
Study Start date:
December 07, 2023
Estimated Completion Date:
December 07, 2026

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.