Camrelizumab as a Maintenance Therapy After Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT04861467
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study was to evaluate the efficacy and safety of Camrelizumab as maintenance therapy in newly diagnosed locally advanced head and neck squamous cell carcinoma subjects after chemoradiation.

Key Dates

Start date
Jun 1, 2021
Status verified
Mar 2021
Primary completion
Jul 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
155 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Camrelizumab
    camrelizumab as maintenance therapy after Chemoradiation(evaluation results：PR/SD)
  • No Intervention: observation
    observation after Chemoradiation
  • Experimental: Exploration：Camrelizumab
    camrelizumab for maintenance after chemoradiation( evaluation results：CR)

Primary Outcome Measure

median progression-free survival(in accordance with RECIST1.1) [ Time Frame: Up to 3 years ]

Central Contacts

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