Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT04944914
Phase
PHASE3
Status
Recruiting
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Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

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

Interventions

  • camrelizumab — DRUG
    Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy
  • stereotactic body radiotherapy — RADIATION
    Patients receive stereotactic body radiotherapy for all oligometastatic lesions as radical therapy to control the disease and reduce any potential adverse impact to living quality. The dosage is based on published clinical studies.

Study Details

We intend to compare the efficacy and safety of immunotherapy plus stereotactic body radiotherapy at oligometastatic lesions and immunotherapy alone among patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical local-regional treatment through this multicenter randomized phase 3 trial.

Key Dates

Start date
Jun 1, 2021
Status verified
Jun 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

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

Arms

  • Experimental: Camrelizumab Plus Stereotactic Body Radiotherapy
    Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy, and then receive stereotactic body radiotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.
  • Active Comparator: Camrelizumab
    Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.

Primary Outcome Measure

Median progression-free survival (PFS) [ Time Frame: 2 years ]

Central Contacts

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