Whole-target Consolidation Therapy Under Systemic Therapy for Oligometastatic Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Jun 20, 2026
  • participants needed
    38
  • sponsor
    Sun Yat-sen University
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Updated on 13 July 2022
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cancer
carcinoma
metastasis
gemcitabine
primary tumor
intensity-modulated radiation therapy
nasopharyngeal carcinoma
camrelizumab

Summary

In this exploratory clinical trial, patients with newly diagnosed distant metastatic nasopharyngeal carcinoma were treated with gemcitabine+ cisplatin+PD-1 inhibitor regimen followed by whole-target radiotherapy (IMRT for local regional lesion, SBRT for distant metastasis) and PD-1 inhibitor long-term maintenance regimen. To investigate the efficacy and safety of "whole target" radiotherapy combined with immuno-maintenance therapy.

Description

This exploratory clinical trial will evaluate tumor control rate, survival, and safety of newly diagnosed distant metastatic nasopharyngeal carcinoma by further adding local regional IMRT, distant metastatic SBRT and immuno-maintenance therapy to the standard regimen of gemcitabine+ cisplatin+ PD-1 inhibitor (historical data). To explore whether the "full target" model can be a better comprehensive therapy for the initial diagnosed distant metastatic nasopharyngeal carcinoma in the era of immunotherapy.

Details
Condition Nasopharyngeal Carcinoma
Treatment Camrelizumab, gemcitabin, cisplatin, Stereotactic Body Radiotherapy, Intensity modulated-radiotherapy
Clinical Study IdentifierNCT05431764
SponsorSun Yat-sen University
Last Modified on13 July 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female; 18-70 years of age
Had histopathologically confirmed nonkeratinizing metastatic NPC that was diagnosed as stage IVb NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary)
Patients who had not received anti-tumor therapy for nasopharyngeal cancer before this clinical trial
Patients evaluated to have a partial response (PR) or stable disease (SD) by head and neck MRI and PET/CT after 3 months of locoregional radiotherapy, and the metastatic lesions were assessed as oligometastatic lesions (the number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3)
Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT
ECOG performance status of 0 or 1
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 6 months

Exclusion Criteria

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
CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency
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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