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).
Treatment for locally recurrent nasopharyngeal carcinoma (LR-NPC) is challenging. Carbon-ion radiotherapy appeared to be an effective treatment for this group of patients, and has substantially improved the 2-year overall survival (OS) to approximately 85%, compared to photon-based intensity-modulated radiotherapy. However, a group of the patients may still develop disease progression after CIRT, and the 2-year progression-free survival (PFS) was approximately 45%-50%. Camrelizumab, a programmed cell death 1 (PD-1) inhibitor, has been demonstrated that it is effective in the recurrent/metastatic nasopharyngeal carcinoma; however, the role of camrelizumab in concurrence with radiotherapy, especially CIRT, for LR-NPC is not clear. The purpose of this phase 2 clinical trial is to compare the efficacy of CIRT plus camrelizumab and CIRT alone in the treatment of LR-NPC. Eligible participants will be randomized (1:1) to 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group). The primary endpoint is progression-free survival. Secondary endpoints include overall survival (OS), local progression-free survival (LPFS), regional progression-free survival (RPFS), and distant metastasis-free survival (DMFS) and toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
Induction chemotherapy with the regimen of gemcitabine plus nedaplatin.
Accelerated carbon-ion beam with pencil beam scanning technique.
An anti-PD-1 antibody.
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-free survival
Duration from randomization to documented disease recurrence or death from any cause, whichever occurs first.
Time frame: 2-year
Overall survival
Duration from randomization to death from any cause.
Time frame: 2-year
Local progression-free survival
Duration from randomization to documented local recurrence or death from any cause, whichever occurs first.
Time frame: 2-year
Regional progression-free survival
Duration from randomization to documented regional recurrence or death from any cause, whichever occurs first.
Time frame: 2-year
Distant metastasis-free survival
Duration from randomization to documented distant metastasis or death from any cause, whichever occurs first.
Time frame: 2-year
Number of participants with adverse events
Incidence of adverse events
Time frame: 2-year
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