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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2026
  • participants needed
    188
  • sponsor
    Sun Yat-sen University
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Updated on 10 July 2021
See if I qualify
carcinoma
iv infusion
chemotherapy regimen
radiofrequency ablation
administration intravenous
nasopharyngeal carcinoma
camrelizumab

Summary

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.

Description

We intend to apply camrelizumab plus stereotactic body radiotherapy at oligometastatic lesions to patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical treatment through this multicenter randomized phase 3 trial to investigate whether stereotactic body radiotherapy at oligometastatic lesions on the basis of immunotherapy can achieve clinical cure among a part of patients with distant metastasis and improve their overall survival.

Details
Condition nasopharyngeal carcinoma, Nasopharyngeal Cancer, Carcinoma, Vulvar Dysplasia and Carcinoma, Advanced Malignancies
Treatment Stereotactic body radiotherapy, Camrelizumab
Clinical Study IdentifierNCT04944914
SponsorSun Yat-sen University
Last Modified on10 July 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female; 18-70 years of age
Primary lesion and regional lymph nodes completed radical radiotherapy 3 months before stereotactic body radiotherapy and diseases well controlled
Underwent at least first-line systemic chemotherapy, regardless of regimen and curative effect
Imageological evidence for oligometastatic lesions (metastatic tissue biopsy preferred but not necessary). The number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3
ECOG performance status of 0 or 1
Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT
If metastatic lesions have received local treatment (surgery, radiofrequency ablation, radiotherapy etc.)
Eligible if treated lesion is well controlled according to imageological examinations, and the lesion does not need stereotactic body radiotherapy
If treated lesion is not controlled according to imageological examinations
Eligible if the treatment is surgery and that stereotactic body radiotherapy is applicable for the treated lesion
Ineligible if the treatment is radiofrequency ablation or radiotherapy
Maximum diameter of brain metastatic lesion no more than 3cm
Maximum diameter of metastatic lesion (brain excluded) no more than 5cm
Maximum diameter of bone metastatic lesion no more than 6cm if attending doctor decides it is safe to apply the treatment
Life expectancy more than 12 weeks

Exclusion Criteria

Immunotherapy (PD-1/PD-L1 or CTLA-4 monoclonal antibody) failure
CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency
History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody
chemotherapy (cytotoxic or molecular targeted) within 4 weeks before stereotactic body radiotherapy
Imageological evidence for spinal cord compression, or tumor less than 3mm away from spinal cord
Patient with brain metastasis who needs decompression surgery
Other malignancy or malignant hydrothorax
Concurrent known or suspicious autoimmune disease, including dementia and epilepsy
Use of large dose corticosteroids within 4 weeks before study drug administration
Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids
Active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening
Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy
Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of 1000cps/ml or hepatitis C virus (HCV) antibody positive
Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment
Pregnancy or lactation
Other ineligible patients according to attending doctor
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