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

NCT07781072 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-08-24

No results posted yet for this study

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.

Conditions

  • Locally Advanced Head and Neck Squamous Cell Carcinoma

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-12
Primary Completion
2028-06-30
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07781072 on ClinicalTrials.gov