Actively Recruiting
SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2026-05-11
148
Participants Needed
1
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
CONDITIONS
Official Title
SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with recurrent or metastatic nasopharyngeal carcinoma
- Histopathological diagnosis of nasopharyngeal carcinoma (WHO types II or III)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No prior treatment for recurrent/metastatic nasopharyngeal carcinoma, including radiotherapy, chemotherapy, immunotherapy, or biotherapy
- No contraindications to immunotherapy and chemoradiotherapy
- At least one lesion suitable for SBRT treatment
- Must have at least one measurable target lesion according to RECIST v1.1 criteria
- Adequate bone marrow function: WBC count ≥ 3 x 10^9/L, neutrophil count ≥ 1.5 x 10^9/L, hemoglobin ≥ 90 g/L, platelet count ≥ 100 x 10^9/L
- Adequate liver function: ALT/AST ≤ 2.5 times the upper limit of normal, total bilirubin ≤ 2.0 times the upper limit of normal
- Adequate kidney function: BUN/creatinine ≤ 1.5 times the upper limit of normal or creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula)
- Use effective contraception during treatment and for three months after treatment
- Provide written informed consent after being informed about the investigational nature of the study
You will not qualify if you...
- Allergy to monoclonal antibodies, PD-1 antibody components, gemcitabine, or cisplatin
- Unexplained fever over 38.5°C, except for tumor-related fever
- Active autoimmune diseases such as uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, or asthma requiring bronchodilator therapy
- Known history of HIV infection, active hepatitis B (HBV-DNA ≥ 10^3 copies/ml), or positive hepatitis C virus antibody
- Heart conditions including New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial infarction within the past year, or significant arrhythmia requiring treatment
- Allergy to large molecule protein products or any component of the study therapy
- Pregnant or breastfeeding
- Prior malignancy except for adequately treated non-melanoma skin cancer, in situ cervical cancer, or papillary thyroid carcinoma
- Receipt of live vaccine within 30 days before planned study therapy
- Psychiatric or substance abuse disorders that might interfere with study participation
- Any other condition, including mental illness or social factors, that may affect ability to consent, cooperate, participate, or interpret study results
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
Actively Recruiting
Research Team
J
Jingjing Miao, MD.
CONTACT
C
Chong Zhao, 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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