The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in R/M NPC
ConditionNasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing University Cancer Hospital
About this trial
Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. Stereotactic body radiotherapy is a potential immunostimulatory therapy that may amplify antitumor response when combined with camrelizumab.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed Written Informed Consent
Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines.
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations.
The peripheral blood EBV DNA copy number can be obtained.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Camrelizumab
DrugCamrelizumab 200mg IV starting day 1 and then every 2 weeks thereafter. Treatment with Camrelizumab will continue until progression or unacceptable toxicity.
Stereotactic body radiotherapy
RadiationImage guided, stereotactic body radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Camrelizumab).
Treatment groups
39 Participants
are divided into 2 treatment groupsGroup A: Camrelizumab aloneActive comparator 1 intervention
Group B: Stereotactic body radiotherapy plus CamrelizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Best overall response (BOR)
As determined by the investigator using RECIST 1.1 criteria between patients receiving Camrelizumab and stereotactic body radiotherapy and those receiving Camrelizumab alone. BOR rate is defined as the number of patients randomized to a given arm with a best overall response of complete response (CR) or partial response (PR) of non-irradiated lesions divided by the total number of patients randomized to the given arm. In order to ascertain this endpoint, efforts will be made so that patients will be followed for 96 weeks or until progression of disease (and treatment cessation), whichever comes first. At each time-point, subjects should have CT/MR of neck, chest, abdomen, and pelvis with contrast.
Time frame
Time Frame: 96 weeksSponsors and contacts
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Source ClinicalTrials.gov