Actively Recruiting
Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma: A Multicenter Randomized Clinical Phase 3 Trial
Led by Sun Yat-sen University · Updated on 2026-04-30
188
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of combining immunotherapy with stereotactic body radiotherapy (SBRT) versus immunotherapy alone for patients with oligometastatic nasopharyngeal carcinoma. This trial focuses on patients whose primary tumors have been well controlled after radical local-regional treatment. The goal is to determine whether adding SBRT to immunotherapy can potentially cure some patients with distant metastases and improve overall survival in this multicenter randomized phase 3 study. Participants are assigned randomly to one of two groups. One group receives camrelizumab, a drug given by intravenous infusion every two weeks, starting two weeks before radiotherapy; they then receive stereotactic body radiotherapy targeting oligometastatic lesions until disease progression, unacceptable side effects, or one year of treatment. The other group receives camrelizumab alone every two weeks under the same conditions. The radiation doses for SBRT follow established clinical study guidelines. During the study, participants will have regular assessments including scans and clinical evaluations to monitor disease status and treatment effects. Researchers will measure outcomes such as median progression-free survival over two years, response rates, overall survival, adverse events, and quality of life scores using validated questionnaires. Safety and treatment adherence will be closely observed throughout the treatment period. The total duration of participation depends on disease progression, treatment tolerance, and study criteria over the two-year observation period.
CONDITIONS
Brief 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 treated with radical radiotherapy completed at least 3 months before stereotactic body radiotherapy and disease well controlled
- Received at least first-line systemic chemotherapy
- Imaging confirming 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
- Eligible for stereotactic body radiotherapy for all metastatic lesions as determined by a multidisciplinary team
- If metastatic lesions previously treated locally and well controlled, no additional radiotherapy needed; if not controlled and treated by surgery, stereotactic body radiotherapy must be applicable
- Maximum brain metastatic lesion diameter no more than 3 cm
- Maximum metastatic lesion diameter (excluding brain) no more than 5 cm; bone metastatic lesions no more than 6 cm if deemed safe
- Life expectancy greater than 12 weeks
You will not qualify if you...
- Previous failure of immunotherapy targeting PD-1/PD-L1 or CTLA-4
- Coronary heart disease grade 2 or higher, arrhythmia with prolonged QTc interval, or cardiac insufficiency
- Severe allergic reaction history to PD-1/PD-L1 or other monoclonal antibodies
- Chemotherapy within 4 weeks prior to stereotactic body radiotherapy
- Radiologic evidence of spinal cord compression or tumor less than 3 mm from spinal cord
- Brain metastasis requiring decompression surgery
- Other active malignancies or malignant pleural effusion
- Known or suspected autoimmune diseases, including dementia and epilepsy
- Use of high-dose corticosteroids within 4 weeks before study drug
- Medical conditions requiring immunosuppressive therapy
- Active tuberculosis or recent anti-tuberculosis treatment within 1 year
- Active or history of autoimmune diseases requiring systemic steroids or immunosuppressants except resolved childhood asthma/atopy or vitiligo
- HIV infection or positive hepatitis B or C markers with specific viral load criteria
- Received any anti-infective vaccine within 4 weeks before enrollment
- Pregnancy or breastfeeding
- Other conditions deemed ineligible by the attending doctor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 2 weeks
Participants receive camrelizumab (200mg, intravenous drip over 60 minutes) every 2 weeks starting 2 weeks before radiotherapy.
1 visit every 2 weeks
Duration - Up to 1 year
Participants receive camrelizumab every 2 weeks and, if assigned, stereotactic body radiotherapy for all oligometastatic lesions. Treatment continues until disease progression, unacceptable toxicity, withdrawal, investigator decision, or up to 1 year.
1 visit every 2 weeks
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
R
Rui You, MD, PhD
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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