Actively Recruiting
Tislelizumab Plus GX Versus Tislelizumab Plus GP in the Treatment of R/M NPC
Led by Fudan University · Updated on 2025-08-14
266
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety and efficacy of tislelizumab combined with GX regimen versus tislelizumab combined with GP regimen in the first-line treatment of nasopharyngeal carcinoma.
CONDITIONS
Official Title
Tislelizumab Plus GX Versus Tislelizumab Plus GP in the Treatment of R/M NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological confirmation of recurrent or metastatic nasopharyngeal carcinoma
- No prior systemic treatment for recurrent or metastatic disease, except if relapse occurred at least 6 months after previous chemotherapy
- Age between 18 and 75 years, any gender
- Performance status of 0 or 1
- At least one measurable lesion according to RECIST v1.1 criteria
- Blood tests showing hemoglobin 90 g/L, neutrophils �b91.5 �d7 10^9/L, and platelets �b980 �d7 10^9/L
- Liver function tests within defined limits: total bilirubin �b91.5 �d7 upper limit, ALT and AST less than 2.5 �d7 upper limit (or 5 �d7 if liver metastasis)
- Renal function with albumin �b928 g/L and serum creatinine �b91.5 �d7 upper limit or creatinine clearance �b960 ml/min
- Coagulation function with APTT and INR less than 1.5 �d7 upper limit
- Women of childbearing potential must have negative pregnancy test within 2 weeks before enrollment and agree to use contraception
- Willingness to provide pathological tissue specimens
- Expected survival of at least 3 months
- Voluntary participation and signed informed consent
You will not qualify if you...
- Patients with local recurrence suitable for surgery or radiotherapy
- History of severe allergy to monoclonal antibody therapy
- Previous treatment with PD-1, PD-L1, or CTLA-4 monoclonal antibodies
- Significant heart disease including NYHA class IV heart failure, unstable angina, recent myocardial infarction, congestive heart failure, or prolonged QT interval
- Autoimmune diseases requiring treatment or history of systemic steroids or immunosuppressants
- Other serious uncontrolled diseases affecting study compliance or results, such as uncontrolled diabetes or lung diseases
- Known active hepatitis B or C infection or immunodeficiency diseases including HIV
- Severe active infections
- Symptomatic central nervous system metastases
- History of other cancers unless cured for more than 5 years
- Serious neurological or psychiatric disorders including dementia or epilepsy
- Drug abuse or conditions interfering with study participation
- Investigator judgment of unsuitability for enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
D
Dongmei Ji, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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