Actively Recruiting
Tislelizumab in Combination With GP or TPC Regimen for the Treatment of Nasopharyngeal Carcinoma With Bone Metastasis.
Led by XIANG YANQUN · Updated on 2024-07-16
90
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open-label phase III clinical trial evaluating the efficacy and safety of the GP（Gemcitabine combined with cisplatin） regimen in combination with Tislelizumab versus the TPC（cisplatin, nab-paclitaxel and capecitabine）regimen in combination with Tislelizumab for the first-line treatment of Nasopharyngeal Carcinoma patients With Bone Metastasis.
CONDITIONS
Official Title
Tislelizumab in Combination With GP or TPC Regimen for the Treatment of Nasopharyngeal Carcinoma With Bone Metastasis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histology or cytology confirmed nasopharyngeal carcinoma
- Bone metastatic nasopharyngeal carcinoma not suitable for local or radical therapy
- Distant bone metastases confirmed by imaging or pathology (AJCC 8th, stage IVB), excluding isolated local skull base invasion
- May have non-measurable distant organ metastases or lymph node lesions per RECIST 1.1
- Bone metastases may include soft tissue osteolytic lesions
- No prior systemic therapy for advanced or metastatic disease; prior chemotherapy or radiotherapy completed over 6 months before enrollment
- Expected survival of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Good organ function as defined by specified blood counts and liver enzyme levels
- Willing and able to comply with study visits, treatment plans, and tests
You will not qualify if you...
- Osteo-oligometastatic nasopharyngeal carcinoma
- Severe hypersensitivity to monoclonal antibodies or tislelizumab
- One or more measurable metastatic organs or lymph node lesions per RECIST 1.1
- No definitive surgery or radiotherapy for spinal cord compression or unstable disease in that area
- Poorly controlled pleural, pericardial effusion, or ascites requiring frequent drainage
- Poorly controlled tumor-related pain or candidates for palliative radiation not yet treated
- Poorly controlled or symptomatic hypercalcemia
- Other malignancies within 5 years except certain low-risk or treated cancers
- History of autoimmune diseases except stable hypothyroidism or controlled type 1 diabetes
- Recent use of systemic immunostimulating drugs or high-dose systemic immunosuppressants
- Prior allogeneic bone marrow or solid organ transplantation
- History of certain lung diseases or active pneumonia at screening
- Active infections including tuberculosis, hepatitis B/C, or HIV
- Significant underlying medical conditions affecting treatment or protocol adherence
- Severe neurological or psychiatric disorders
- Peripheral neuropathy grade 2 or higher
- Pregnant or breastfeeding females
- Major cardiovascular diseases including recent heart attack, unstable arrhythmias, or heart failure with reduced ejection fraction
AI-Screening
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Trial Site Locations
Total: 1 location
1
SunYat-senU
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yanqun Xiang
CONTACT
G
Guoying Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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