The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in R/M NPC

Sponsor
Chongqing University Cancer Hospital
Study ID
NCT04830267
Phase
PHASE2
Status
Recruiting
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Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab 200mg IV starting day 1 and then every 2 weeks thereafter. Treatment with Camrelizumab will continue until progression or unacceptable toxicity.
  • Stereotactic body radiotherapy — RADIATION
    Image 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).

Study Details

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.

Key Dates

Start date
Mar 1, 2021
Status verified
Mar 2024
Primary completion
Aug 1, 2024
Completion
Aug 1, 2026

Study Design

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

Arms

  • Active Comparator: Camrelizumab alone
    Camrelizumab 200mg IV every 2 weeks
  • Experimental: Stereotactic body radiotherapy plus Camrelizumab
    Stereotactic body radiotherapy 27Gy/3F and Camrelizumab 200mg IV every 2 weeks

Primary Outcome Measure

Best overall response (BOR) [ Time Frame: Time Frame: 96 weeks ]

Central Contacts

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