Actively Recruiting
Whole-target Consolidation Therapy Under Systemic Therapy for Oligometastatic Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2022-06-24
38
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Whole-target Consolidation Therapy Under Systemic Therapy for Oligometastatic Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 70 years
- Histopathologically confirmed nonkeratinizing metastatic nasopharyngeal carcinoma diagnosed as stage IVb
- No prior anti-tumor therapy for nasopharyngeal cancer
- Partial response or stable disease after 3 months of locoregional radiotherapy
- Oligometastatic lesions: no more than 5 total metastatic lesions and no more than 3 lesions within a single organ
- Suitable for stereotactic body radiotherapy for all metastatic lesions
- ECOG performance status of 0 or 1
- Brain metastatic lesion diameter no more than 3 cm
- Metastatic lesion diameter (excluding brain) no more than 5 cm
- Bone metastatic lesion diameter no more than 6 cm if deemed safe by doctor
- Life expectancy over 6 months
You will not qualify if you...
- History of severe allergic reaction to PD-1/PD-L1 or other monoclonal antibodies
- 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 fluid accumulation in chest
- Known or suspected autoimmune diseases, including dementia and epilepsy
- Moderate or worse coronary heart disease, arrhythmia, or heart failure
- Use of high-dose corticosteroids within 4 weeks before study drug
- Need for immunosuppressive medications or doses of corticosteroids
- Active tuberculosis or treatment within 1 year prior
- Active or history of autoimmune diseases requiring systemic steroids or immunosuppressants except vitiligo or resolved childhood asthma/atopy
- Known HIV infection or active hepatitis B or C infection
- Received any anti-infective vaccine within 4 weeks prior
- Pregnancy or breastfeeding
- Other conditions deemed ineligible 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
Department of Nasopharyngeal Carcinoma, 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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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