Actively Recruiting
Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2026-04-30
188
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
A
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 70 years
- Primary lesion and regional lymph nodes completed radical radiotherapy at least 3 months before stereotactic body radiotherapy with well-controlled disease
- Received at least first-line systemic chemotherapy regardless of regimen or effect
- Image evidence of oligometastatic lesions with no more than 5 total metastatic lesions and no more than 3 lesions in a single organ
- ECOG performance status of 0 or 1
- Suitable for stereotactic body radiotherapy for all metastatic lesions according to multidisciplinary team
- If metastatic lesions previously treated locally: eligible if treated lesions are well controlled or if surgery was done and radiotherapy is applicable; ineligible if prior radiofrequency ablation or radiotherapy failed
- Brain metastatic lesions no larger than 3 cm in diameter
- Non-brain metastatic lesions no larger than 5 cm, bone lesions no larger than 6 cm if deemed safe
- Life expectancy over 12 weeks
You will not qualify if you...
- Prior failure of immunotherapy with PD-1/PD-L1 or CTLA-4 monoclonal antibodies
- Coronary heart disease grade 2 or higher, arrhythmia with QTc interval over 450 ms (male) or 470 ms (female), or cardiac insufficiency
- Severe allergy to PD-1/PD-L1 or other monoclonal antibody ingredients
- Chemotherapy within 4 weeks before stereotactic body radiotherapy
- Evidence of spinal cord compression or tumor within 3 mm of spinal cord
- Brain metastasis requiring decompression surgery
- Other cancers or malignant hydrothorax
- Known or suspected autoimmune diseases including dementia and epilepsy
- Use of high-dose corticosteroids within 4 weeks before study drug
- Medical conditions requiring immunosuppressive medications or corticosteroids
- Active tuberculosis or treatment within 1 year prior to screening
- Active or history of autoimmune diseases requiring systemic steroids or immunosuppressants except resolved childhood asthma/atopy or vitiligo
- HIV infection, hepatitis B with high viral load, or hepatitis C infection
- Received any anti-infective vaccine within 4 weeks prior to enrollment
- Pregnancy or breastfeeding
- Other ineligible conditions as determined by attending doctor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
M
Ming-Yuan Chen, MD, PhD
CONTACT
R
Rui You, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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