Actively Recruiting
Neoadjuvant Chemotherapy Plus Toripalimab in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Led by Zhejiang Cancer Hospital · Updated on 2023-04-14
89
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neoadjuvant chemotherapy plus toripalimab in patients with locoregionally advanced nasopharyngeal carcinoma
CONDITIONS
Official Title
Neoadjuvant Chemotherapy Plus Toripalimab in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosed with non-keratinizing carcinoma according to World Health Organization criteria
- Diagnosed with locoregionally advanced nasopharyngeal carcinoma using the 8th edition AJCC/UICC staging system
- ECOG performance score of 0 to 1
- Normal bone marrow function: white blood cell count > 4 x 10^9/L, hemoglobin > 90 g/L, platelet count > 100 x 10^9/L
- Normal thyroid function, amylase and lipase levels, pituitary function, inflammation and infection markers, myocardial enzymes, and ECG results
- For patients over 50 with smoking history, normal lung function is required
- Normal liver and kidney function: total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance ≥ 60 ml/min
- Signed informed consent and willingness to comply with study requirements
- Use of reliable contraceptive methods from screening to 1 year after treatment for participants with pregnancy potential
You will not qualify if you...
- Positive hepatitis B surface antigen with HBV DNA > 1 × 10^3 copies/ml or positive hepatitis C antibody
- Positive HIV test or diagnosed with AIDS
- Active tuberculosis within past 1 year or history of active tuberculosis over 1 year without completed anti-tuberculosis treatment
- Active or suspected autoimmune diseases requiring systemic treatment, except certain controlled conditions
- Previous interstitial lung disease or pneumonia treated with steroids
- Chronic systemic glucocorticoid or immunosuppressive therapy (inhaled or topical corticosteroids allowed)
- Uncontrolled heart disease, including heart failure NYHA level ≥ 2, unstable angina, recent myocardial infarction, or arrhythmia requiring treatment
- Pregnant or breastfeeding women
- Previous or concurrent other cancers except certain treated skin, cervical, or thyroid cancers
- Allergy to macromolecular protein preparations or components of nivolumab
- Active infections requiring systemic treatment
- Receipt of live vaccines within 30 days before nivolumab
- History of organ transplantation
- History of psychiatric illness, alcoholism, drug abuse, or other conditions compromising safety or compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
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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