SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma
- Conditions
- Nasopharyngeal Carcinoma
- Registration Number
- NCT06323239
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Diagnosed as recurrence/metastatic NPC<br><br> - Histopathological diagnosis of NPC(WHO II/III)<br><br> - ECOG 0-1 point<br><br> - No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or<br> biotherapy;<br><br> - No contraindications to immunotherapy and chemoradiotherapy;<br><br> - At least one lesion could receive SBRT safely;<br><br> - Subject must have a measurable target lesion based on RECIST v1.1;<br><br> - Adequate marrow function: WBC count = 3×10E9/L, NE count = 1.5×10E9/ L, HGB = 90g/L,<br> PLT count = 100×10E9/L;<br><br> - Adequate liver function: ALT/AST = 2.5×ULN, TBIL = 2.0×ULN;<br><br> - Adequate renal function: BUN/CRE = 1.5×ULN or endogenous creatinine clearance =<br> 60ml/min (Cockcroft-Gault formula);<br><br> - Take effective contraceptions during and three months after treatment;<br><br> - Patients must be informed of the investigational nature of this study and give<br> written informed consent.<br><br>Exclusion Criteria:<br><br> - Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and<br> cisplatin;<br><br> - Unexplained fever > 38.5 #, except for tumor fever;<br><br> - Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis,<br> nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator<br> therapy);<br><br> - Have a known history of human immunodeficiency virus (HIV), active Hepatitis B<br> (HBV-DNA =10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;<br><br> - Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial<br> -infarction within 1 year, or clinically meaningful arrhythmia that requires<br> treatment; Have known allergy to large molecule protein products or any compound of<br> study therapy;<br><br> - Pregnant or breastfeeding;<br><br> - Prior malignancy except adequately treated non-melanoma skin cancer, in situ<br> cervical cancer, and papillary thyroid carcinoma;<br><br> - Have received a live vaccine within 30 days of planned start of study therapy Has<br> psychiatric drug or substance abuse disorders that would interfere with cooperation<br> with the requirements of the trial;<br><br> - Any other condition, including mental illness or domestic/social factors, deemed by<br> the investigator to be likely to interfere with a patient's ability to sign informed<br> consent, cooperate and participate in the study, or interferes with the<br> interpretation of the results.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Overall Survival;Objective Response Rate;Disease Control Rate;Adverse Events;QoL