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Compares treatment options for Nasopharyngeal Carcinoma
Official title Tislelizumab Plus GX Versus Tislelizumab Plus GP in the Treatment of R/M NPC
ClinicalTrials.gov ID: NCT06177301
What this study is testing
What is Tislelizumab combined with GX?
Tislelizumab combined with GX 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
- 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.
- 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 to 75
You may be able to join if
- Histological or cytological examination confirmed recurrence or metastasis of nasopharyngeal carcinoma;
- Patients who have not previously received systemic treatment for recurrent or metastatic diseases (For patients who have previously received...
- Age: 18-75 years old, male or female;
- Perfomance Status: 0\~1;
- At least one measurable lesion (according to RECIST v1.1, long diameter of measurable lesion scanned by spiral CT should be ≥ 10 mm or short diameter...
You likely can't join if
- Patients with local recurrence and suitable for surgery or radiotherapy;
- Patients with a known history of severe allergies to monoclonal antibody therapy;
- Patients who had previously received PD-1 monoclonal antibody or PD-L1 monoclonal antibody or CTLA4 monoclonal antibody;
- Clinical significance of heart disease, including severe cardiac insufficiency : New York Heart Association (NYHA) cardiac insufficiency grade IV...
- Patients with autoimmune diseases requiring treatment, or patients with a history of systemic use of steroids / immunosuppressive agents, such as...
- Other serious and uncontrollable concomitant diseases that may affect the compliance of the program or interfere with the interpretation of the...
See the full eligibility criteria
- Histological or cytological examination confirmed recurrence or metastasis of nasopharyngeal carcinoma;
- Patients who have not previously received systemic treatment for recurrent or metastatic diseases (For patients who have previously received induction chemotherapy, adjuvant chemotherapy or concurrent chemoradiotherapy...
- Age: 18-75 years old, male or female;
- Perfomance Status: 0\~1;
- At least one measurable lesion (according to RECIST v1.1, long diameter of measurable lesion scanned by spiral CT should be ≥ 10 mm or short diameter of swollen lymph node should be ≥ 15 mm; according to RECIST vl.1...
- Blood routine examination: 1) Hemoglobin (HB)≥ 90g / L; 2) Neutrophil count (ANC) ≥ 1.5 × 109 / L; 3) platelets (PLT) ≥ 80 × 109 / L;
- Liver function: 1) Serum total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanine aminotransferase (ALT), aspartate aminotransferase (AST])\< 2.5 × ULN; if liver metastasis, ALT and AST ≤ 5 × ULN...
- Coagulation function : APTT and international normalized ratio (INR)\< 1.5 × UNL;
- Patients of childbearing age agree to take appropriate contraceptive measures. Serum pregnancy test was negative in women of childbearing age within 2 weeks before enrollment.
- Patients agree to provide pathological tissue specimens (wax blocks or paraffin tissue sections 5-10 pieces) ;
- Expected survival ≥ 3 months;
- Patients volunteered to participate in this study and signed informed consent;
- Patients with local recurrence and suitable for surgery or radiotherapy;
- Patients with a known history of severe allergies to monoclonal antibody therapy;
- Patients who had previously received PD-1 monoclonal antibody or PD-L1 monoclonal antibody or CTLA4 monoclonal antibody;
- Clinical significance of heart disease, including severe cardiac insufficiency : New York Heart Association (NYHA) cardiac insufficiency grade IV, unstable angina, acute myocardial infarction within 6 months before...
- Patients with autoimmune diseases requiring treatment, or patients with a history of systemic use of steroids / immunosuppressive agents, such as : hypophysitis, pneumonia, colitis, hepatitis, nephritis...
- Other serious and uncontrollable concomitant diseases that may affect the compliance of the program or interfere with the interpretation of the results, including uncontrolled diabetes, or lung diseases (interstitial...
- Known hepatitis B (HBV) (HBsAg positive and HBV-DNA ≥ 103IU / ml), hepatitis C ( HCV) infection (HCV antibody positive and HCV-RNA measurable) ; and other people with acquired and congenital immunodeficiency diseases...
- Severe active infection;
- Symptomatic patients with central nervous system metastasis;
- Patients with a history of other malignant tumors (unless those who have been cured for more than 5 years);
- Have a serious history of neurological or psychiatric disorders, including dementia or epilepsy;
- Drug abuse, medical, psychological or social conditions that may interfere with the participant 's participation in the study or the evaluation of the study results;
- Researchers believe that patients who are not suitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.