Carbon-Ion Radiotherapy Plus Camrelizumab for Locally Recurrent Nasopharyngeal Carcinoma

Sponsor
Shanghai Proton and Heavy Ion Center
Study ID
NCT04143984
Phase
PHASE2
Status
Unknown

Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

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

Interventions

  • Induction chemotherapy — DRUG
    Induction chemotherapy with the regimen of gemcitabine plus nedaplatin.
  • Carbon-ion radiotherapy — RADIATION
    Accelerated carbon-ion beam with pencil beam scanning technique.
  • Camrelizumab — DRUG
    An anti-PD-1 antibody.

Study Details

The purpose of this trial is to examine the role of camrezlizumab in addition to carbon-ion radiotherapy (CIRT) for patients with locally recurrent nasopharyngeal carcinoma. According to the plan, a total of 146 patients will be recruited and randomized into: 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group).

Key Dates

Start date
Jan 19, 2021
Status verified
Apr 2022
Primary completion
Dec 20, 2025
Completion
Dec 20, 2025

Study Design

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

Arms

  • Active Comparator: Arm-C
    Patients will receive induction chemotherapy followed by carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE).
  • Experimental: Arm-CC
    Patients will receive induction chemotherapy followed by carbon-ion radiotherapy and camrelizumab. In details, patients will receive carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE); in addition, patients will also receive camrelizumab of 200 mg (IV.), every 2 weeks, started with carbon-ion radiotherapy for a maximal period of 1 year.

Primary Outcome Measure

Progression-free survival [ Time Frame: 2-year ]

Central Contacts

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