Neoadjuvant SBRT Sequential Tislelizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Study

Status: Recruiting

Location: See all (2) locations...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 2

SUMMARY

Exploring the efficacy and safety of Tislelizumab combined with stereotactic body radiation therapy (SBRT) as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (HNSCC).

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 70

Healthy Volunteers: f

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• Pathologically confirmed, initially treated, surgically resectable head and neck squamous cell carcinoma.

• Clinical stage III to IVB (AJCC 8th edition), except HPV-positive oropharyngeal cancer

• Following multidisciplinary discussions involving otolaryngologists and radiation oncologists, the assessment concluded that the tumor is resectable or marginally resectable and suitable for preoperative SBRT

• Karnofsky Performance Status score ≥ 70

• Ages 18 to 70

• The primary organ functions meet the test requirements

• Patients participate voluntarily and sign informed consent forms

Locations

Other Locations

China

Sun Yat-sen University Cancer Center

NOT_YET_RECRUITING

Guangzhou

Sun Yat-sen University Cancer Center

RECRUITING

Guangzhou

Contact Information

Primary

Chun-Yan Chen

chenchuny@sysucc.org.cn

13826423812

Backup

Ya-Ni Zhang

zhangyn1@sysucc.org.cn

15914271501

Time Frame

Start Date: 2025-04-15

Estimated Completion Date: 2029-12-31

Participants

Target number of participants: 24

Treatments

Experimental: SBRT combined with PD-1

Week 1: SBRT radiation therapy administered as 24Gy/3f, on days 1, 3, and 5. Weeks 2-5: Tislelizumab 200mg intravenous drip every 3 weeks, for a total of two cycles.

Related Therapeutic Areas

Head and Neck Squamous Cell Carcinoma (HNSCC)

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Neoadjuvant SBRT Sequential Tislelizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Study

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