A Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck Cancer

Sponsor
West China Hospital
Study ID
NCT04405154
Phase
PHASE2
Status
Unknown

Conditions

  • Head and Neck Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — BIOLOGICAL
    Administered as an intravenous (IV) infusion every 2 weeks (Q2W): 14 days prior to radiation, then Day 1 of radiation and then every 14 days for total 8 doses.
  • Cisplatin — DRUG
    75-100 mg/m\^2 administered as an IV infusion Q3W, for a total of 3 doses, at the same time as radiation: Day 1, Day 22, Day 43 of radiation.
  • IMRT or VMAT — RADIATION
    66-70 Gy given in 33-35 fractions over 6-7 weeks.

Study Details

The goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in addition to chemoradiation, the standard treatment for LA-HNSCC.

Key Dates

Start date
Jun 1, 2020
Status verified
May 2020
Primary completion
May 31, 2023
Completion
May 31, 2025

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Arm
    Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin.

Primary Outcome Measure

Objective Response Rate [ Time Frame: 6 months ]

Central Contacts

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