Clinical trial NCT06177301: Tislelizumab Plus GX Versus Tislelizumab Plus GP in the Treatment of R/M NPC
Official title: A Phase III Clinical Study of Tislelizumab Combined With GX Regimen Versus Tislelizumab Combined With GP Regimen in the First-line Treatment of Recurrence or Metastasis (R/M) Nasopharyngeal Carcinoma (NPC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Histological or cytological examination confirmed recurrence or metastasis of nasopharyngeal carcinoma;
2. 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, patients who relapsed at least 6 months after the cessation of chemotherapy can be enrolled).
3. Age: 18-75 years old, male or female;
4. Perfomance Status: 0\~1;
5. 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 standards, a previously treated lesion with local treatment can be used as target lesions after clear progress);
6. Blood routine examination: 1) Hemoglobin (HB)≥ 90g / L; 2) Neutrophil count (ANC) ≥ 1.5 × 109 / L; 3) platelets (PLT) ≥ 80 × 109 / L;
7. 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; Renal function: Albumin ≥ 28g / L ；Serum creatinine (Cr) ≤ 1.5 × ULN，or creatinine clearance rate ≥ 60 ml / min ;
8. Coagulation function : APTT and international normalized ratio (INR)\< 1.5 × UNL;
9. 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.
10. Patients agree to provide pathological tissue specimens (wax blocks or paraffin tissue sections 5-10 pieces) ;
11. Expected survival ≥ 3 months;
12. Patients volunteered to participate in this study and signed informed consent;

Exclusion Criteria:

1. Patients with local recurrence and suitable for surgery or radiotherapy;
2. Patients with a known history of severe allergies to monoclonal antibody therapy;
3. Patients who had previously received PD-1 monoclonal antibody or PD-L1 monoclonal antibody or CTLA4 monoclonal antibody;
4. 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 screening, congestive heart failure, Q-Tc interval greater than 500ms;
5. 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, hyperthyroidism, hypothyroidism;
6. 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 pneumonia, obstructive pulmonary disease, and symptomatic bronchial spasm) ;
7. Known hepatitis B (HBV) (HBsAg positive and HBV-DNA ≥ 103IU / ml), hepatitis C ( HCV) infection (HCV antibody positive and HCV-RNA measurable) ; and other subjects with acquired and congenital immunodeficiency diseases, including, but not limited to, those infected with HIV;
8. Severe active infection;
9. Symptomatic patients with central nervous system metastasis;
10. Patients with a history of other malignant tumors (unless those who have been cured for more than 5 years);
11. Have a serious history of neurological or psychiatric disorders, including dementia or epilepsy;
12. 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;
13. Researchers believe that patients who are not suitable for enrollment.

Primary outcomes:
measure: To compare the progression-free survival of tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the ITT analysis set evaluated by the researchers according to RECIST v1.1.
timeFrame: up to approximately 3 years
Secondary outcomes:
measure: To compare the objective response rate of tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the ITT analysis set evaluated by the researchers according to RECISTv1.1.
timeFrame: up to approximately 3 years
Other outcomes:
measure: To compare the duration of response of R/M NPC patients treated with tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the intention-to-treat (ITT) analysis set evaluated by the researchers according to RECISTv1.1.
timeFrame: up to approximately 3 years
measure: To compare the overall survival (OS) of R/M NPC patients treated with tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the intention-to-treat (ITT) analysis set evaluated by the researchers according to RECISTv1.1.
timeFrame: up to approximately 3 years
measure: To compare the safety and tolerance of R/M NPC patients treated with tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the intention-to-treat (ITT) analysis set evaluated by the researchers according to RECISTv1.1.
timeFrame: up to approximately 3 years
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Dongmei Ji, M.D
role: PRINCIPAL_INVESTIGATOR
References: