RecruitingPhase 3NCT04944914

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

Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma: A Multicenter Randomized Clinical Phase 3 Trial


Sponsor

Sun Yat-sen University

Enrollment

188 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding targeted radiation (called stereotactic body radiotherapy, or SBRT) to an immunotherapy drug (camrelizumab) works better than immunotherapy alone for people with nasopharyngeal (throat/nasal) cancer that has spread to a small number of places in the body (called oligometastatic disease). **You may be eligible if...** - You are between 18 and 70 years old - You have nasopharyngeal cancer that has spread to no more than 5 spots total, with no more than 3 spots in any single organ - Your primary cancer site was already treated with radiation at least 3 months ago and is under control - You have already received at least one round of chemotherapy - You are generally in good health and able to carry out daily activities (ECOG 0 or 1) - Your cancer spots are small enough (brain spots under 3 cm, others under 5 cm) to be safely treated with SBRT - You have a life expectancy of more than 12 weeks **You may NOT be eligible if...** - A previous immunotherapy drug (like a PD-1 or CTLA-4 inhibitor) stopped working for you - You have a serious heart condition or irregular heartbeat - You have an active autoimmune disease (such as rheumatoid arthritis or inflammatory bowel disease) - You have active tuberculosis or HIV, or hepatitis B/C at certain levels - You are pregnant or breastfeeding - Your cancer is pressing on your spinal cord, or you need urgent brain surgery - You have taken high-dose steroids or immunosuppressants recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcamrelizumab

Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy

RADIATIONstereotactic body radiotherapy

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.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT04944914


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