Combining camrelizumab with targeted radiotherapy for advanced nasopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial aims to compare the effectiveness and safety of camrelizumab combined with stereotactic body radiotherapy against camrelizumab alone in patients with oligometastatic nasopharyngeal carcinoma. Participants must have well-controlled primary lesions following radical treatment and present with a limited number of metastatic lesions. The study will assess whether the addition of targeted radiotherapy can enhance overall survival and potentially lead to clinical cures in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female; 18-70 years of age.
2. Primary lesion and regional lymph nodes completed radical radiotherapy 3 months before stereotactic body radiotherapy and diseases well controlled.
3. Underwent at least first-line systemic chemotherapy, regardless of regimen and curative effect.
4. 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.
5. ECOG performance status of 0 or 1.
6. Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.
7. 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.
8. Maximum diameter of brain metastatic lesion no more than 3cm.
9. 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.
10. Life expectancy more than 12 weeks.

Exclusion Criteria:

1. Immunotherapy (PD-1/PD-L1 or CTLA-4 monoclonal antibody) failure.
2. CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.
3. History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody.
4. chemotherapy (cytotoxic or molecular targeted) within 4 weeks before stereotactic body radiotherapy.
5. Imageological evidence for spinal cord compression, or tumor less than 3mm away from spinal cord.
6. Patient with brain metastasis who needs decompression surgery.
7. Other malignancy or malignant hydrothorax.
8. Concurrent known or suspicious autoimmune disease, including dementia and epilepsy.
9. Use of large dose corticosteroids within 4 weeks before study drug administration.
10. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids.
11. Active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening
12. 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.
13. 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.
14. Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.
15. Pregnancy or lactation.
16. Other ineligible patients according to attending doctor.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Ming-Yuan Chen, MD, PhD
• Email: chmingy@mail.sysu.edu.cn
• Phone: 86-20-8734-3361

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Camrelizumab with Famitinib for rare head and neck cancers

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.