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Neoadjuvant Radiotherapy Combined With Toripalimab for Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT05861557 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-05-17

No results posted yet for this study

Summary

This is a phase II study. Twenty-three patients with locally advanced head and neck squamous cell carcinoma were planned to be enrolled to assess the efficacy and safety of neoadjuvant immunotherapy combined with radiotherapy.

Conditions

  • Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Toripalimab

240mg, Q3W，I.V., D1, 2 cycles (1cycle of toripalimab before and after the SBRT radiotherapy, respectively), followed by the maintenance of toripalimab for 6 months after the surgery.

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

Subjects were treated with SBRT radiotherapy (8Gy\*5Fx), after 1 cycle of immunotherapy

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Tianjin Medical University General Hospital

    lead OTHER

Principal Investigators

  • Huifang Zhou · Tianjin Medical University General Hospital

  • Ximei Zhang · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-20
Primary Completion
2024-05-20
Completion
2025-05-20

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 NCT05861557 on ClinicalTrials.gov