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RECRUITING
NCT07781072
PHASE2

Sintilimab Plus Hypofractionated Radiotherapy Followed by Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine

View on ClinicalTrials.gov

Summary

Most patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed with locally advanced disease. While cisplatin-based chemoradiotherapy remains the standard-of-care treatment for this patient population, it is still associated with a high rate of disease recurrence. Given the relatively high mutational burden of HNSCC, immunotherapy has emerged as a promising therapeutic strategy. The addition of PD-1 inhibitors to induction chemotherapy has been shown to improve antitumor responses without increasing treatment-related toxicity. In addition, radiotherapy can further potentiate systemic antitumor immune responses. Sintilimab, a PD-1 monoclonal antibody, has demonstrated robust antitumor activity across multiple solid malignancies. Early clinical evidence indicates a synergistic antitumor effect when combined with hypofractionated radiotherapy. Nevertheless, clinical data regarding the combination of sintilimab with chemoradiotherapy in locally advanced HNSCC remain limited. Accordingly, we designed a multicenter, single-arm phase II trial to evaluate the efficacy and safety of sintilimab in combination with definitive chemoradiotherapy for patients with locally advanced HNSCC.

Official title: Sintilimab Combined With Hypofractionated Radiotherapy Followed by Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Single-Arm, Phase II Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2026-06-12

Completion Date

2030-12-31

Last Updated

2026-08-24

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Hypofractionated Induction RT (5Gy×3) Followed by Sintilimab, Platinum-Based CCRT and Sintilimab

Induction therapy consists of two cycles of sintilimab injection combined with hypofractionated radiotherapy (5 Gy × 3), followed by sequential concurrent chemoradiotherapy delivered at 50 Gy in 25 fractions with two cycles of platinum-based chemotherapy (cisplatin, nedaplatin or carboplatin). Upon completion of chemoradiotherapy, patients are administered maintenance sintilimab injection for a minimum of six months.

Locations (1)

Second Affiliated Hospital Of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China