Actively Recruiting
Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma
Led by Fifth Affiliated Hospital, Sun Yat-Sen University · Updated on 2022-04-14
28
Participants Needed
1
Research Sites
248 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.
CONDITIONS
Official Title
Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with nasopharyngeal carcinoma by histology or cytology
- Newly diagnosed with metastatic nasopharyngeal carcinoma
- Completed 4-6 cycles of gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen with at least stable disease
- Less than 5 distant organ metastases excluding primary tumor and cervical lymph node metastasis, suitable for SBRT radiotherapy
- ECOG performance status score 0-2
- Age between 18 and 70 years
- Adequate major organ function including neutrophil count 2.0 10^9/L, platelet count 100 10^9/L, hemoglobin 90 g/L
- Serum albumin 28 g/L
- ALT and AST 2.5 upper limit of normal; if liver metastasis present, ALT and AST 5 upper limit of normal
- Serum creatinine 1.5 upper limit of normal or creatinine clearance 60 mL/min
- INR 1.5 upper limit of normal and APTT 1.5 upper limit of normal
- Life expectancy of at least 12 weeks
- Voluntarily agrees to participate, signs informed consent, and cooperates with follow-up
You will not qualify if you...
- Recurrent and metastatic nasopharyngeal carcinoma after initial treatment
- Prior treatment of primary lesion or metastasis except standard first-line gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen
- Central nervous system metastasis (confirmed or suspected)
- Allergy or intolerance to PD-1 monoclonal antibody or capecitabine
- Uncontrolled cardiac conditions including NYHA Grade II or higher heart failure, unstable angina, recent myocardial infarction, or arrhythmias requiring intervention
- Severe infection within 4 weeks before study drug use
- History of other malignancies within 5 years except certain cured cancers
- Prior investigational drug use or participation in other clinical studies except observational or follow-up studies
- Recent systemic corticosteroids or immunosuppressive treatments except certain local or hormone therapies
- Recent anti-tumor or live vaccines within 4 weeks before study drug
- Recent excessive surgery or severe trauma within 4 weeks
- Active or recent autoimmune diseases within 2 years requiring intervention
- History of immunodeficiency, organ or bone marrow transplantation
- Active or recent pulmonary tuberculosis infection
- Active hepatitis B or C infection
- Coagulation abnormalities or bleeding disorders
- Uncontrolled hypertension or cardiac arrhythmias grade II or higher
- Significant proteinuria
- Current diarrhea-related diseases
- History of drug or alcohol abuse or current antiepileptic drug use
- Pregnancy or lactation
- Considered unsuitable for inclusion by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fifth Affilliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Actively Recruiting
Research Team
Z
Zhigang MD Liu, PhD
CONTACT
Z
Zhigang MD Liu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here