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New treatment option for Nasopharyngeal Carcinoma
Official title Tislelizumab in Combination With GP or TPC Regimen for the Treatment of Nasopharyngeal Carcinoma With Bone Metastasis.
ClinicalTrials.gov ID: NCT06383780
What this study is testing
What is GP combined with Tislelizumab?
GP combined with Tislelizumab is an investigational medicine, being studied as a potential treatment for nasopharyngeal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age≥ 18 years.
- Histology or cytology confirmed nasopharyngeal carcinoma.
- Metastatic nasopharyngeal carcinoma of bone that is not suitable for local or radical therapy.
- Distant bone metastases confirmed by imaging (two images) or pathology (plus one image) (AJCC 8th, stage IVB), except for isolated local invasion of...
- With or without metastases from other organs, but lesions may be non-measurable distant organ metastases or lymph node lesions (as assessed by RECIST...
You likely can't join if
- Patients with osteo-oligometastatic nasopharyngeal carcinoma.
- Previous history of severe hypersensitivity to any component of other monoclonal antibodies or tislelizumab monoclonal mab.
- Patients have ≥ 1 metastatic organs or lymph node lesions that can be measured (assessed according to RECIST 1.1)
- No definitive surgical and/or radiotherapy for spinal cord compression, or for previously diagnosed and treated spinal cord compression, no evidence...
- Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelling catheters, such as PleurX...
- Poorly controlled tumor-related pain. Patients requiring analgesic therapy must receive a stable dose before enrolling in the study. Patients who are...
See the full eligibility criteria
Who can join
- Age≥ 18 years.
- Histology or cytology confirmed nasopharyngeal carcinoma.
- Metastatic nasopharyngeal carcinoma of bone that is not suitable for local or radical therapy.
- Distant bone metastases confirmed by imaging (two images) or pathology (plus one image) (AJCC 8th, stage IVB), except for isolated local invasion of the base bone of the skull.
- With or without metastases from other organs, but lesions may be non-measurable distant organ metastases or lymph node lesions (as assessed by RECIST 1.1).
- Bone metastases may contain soft tissue components of osteolytic lesions.
- Patients have not previously received systemic therapy for advanced or metastatic disease, and prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant chemotherapy must have been completed more than 6...
- Expected survival ≥ 3 months.
- According to the Eastern Cooperative Oncology Group (ECOG) criteria, the performance status score is 0 or 1.
- Good organ function:Hemoglobin \> 8.0 g/dl; Absolute neutrophil count (ANC) \>1,500/mm3; Platelet count\> 100,000/μl; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase and glutamate...
- Willing and able to comply with planned visits, treatment plans, laboratory tests, and other research procedures.
What rules you out
- Patients with osteo-oligometastatic nasopharyngeal carcinoma.
- Previous history of severe hypersensitivity to any component of other monoclonal antibodies or tislelizumab monoclonal mab.
- Patients have ≥ 1 metastatic organs or lymph node lesions that can be measured (assessed according to RECIST 1.1)
- No definitive surgical and/or radiotherapy for spinal cord compression, or for previously diagnosed and treated spinal cord compression, no evidence that the disease was clinically stable for ≥ 2 weeks prior to...
- Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelling catheters, such as PleurX ® catheters, are allowed to participate.
- Poorly controlled tumor-related pain. Patients requiring analgesic therapy must receive a stable dose before enrolling in the study. Patients who are candidates for palliative radiation therapy (e.g., bone metastases or...
- Poorly controlled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium or calcium\> 12 mg/dL or corrected serum calcium higher than ULN)
- Malignancy with malignancies other than nasopharyngeal carcinoma within 5 years prior to enrollment, with negligible risk of metastasis or death (e.g., expected 5-year OS\>90%) and expected radical results after...
- History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis related...
- Receiving systemic immunostimulating drugs (including but not limited to interferon or IL-2) within 4 weeks prior to enrollment or within 5 half-lives of the drug (whichever is shorter).
- Receiving systemic corticosteroids (\> 10 mg/d prednisone equivalent) or other systemic immunosuppressants (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate...
- Patients who have previously undergone allogeneic bone marrow transplantation or have previously undergone solid organ transplantation.
- History of idiopathic pulmonary fibrosis, drug-induced pneumonia, organic pneumonia (ie, bronchiolitis obliterans), history of idiopathic pneumonia or chest CT scan showing evidence of active pneumonia at screening.
- Active infection, including tuberculosis (clinical diagnosis includes clinical history, physical examination and imaging findings, and TB examination according to local medical practice), hepatitis B (known HBV surface...
- Clinically significant underlying medical conditions (e.g., dyspnea, pneumonia, pancreatitis, poorly controlled diabetes, active or poorly controlled infections, drugs, or alcohol) that the investigator believes may...
- Presence of severe neurological or psychiatric disorders, including dementia and seizures.
- Accompanied by NCI-CTCAE ≥ grade 2 peripheral neuropathy.
- Pregnant or lactating female patients.
- Major cardiovascular diseases, such as New York Heart Association heart disease (grade II or higher, see Appendix 6), myocardial infarction within 3 months prior to enrollment, unstable arrhythmias or unstable angina...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.