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)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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, patients who relapsed at least 6 months after the cessation of chemotherapy can be enrolled).

• 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 standards, a previously treated lesion with local treatment can be used as target lesions after clear progress);

• 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; Renal function: Albumin ≥ 28g / L ;Serum creatinine (Cr) ≤ 1.5 × ULN,or creatinine clearance rate ≥ 60 ml / min ;

• 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;

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Dongmei Ji, M.D
jidongmei2000@hotmail.com
021-64175590
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 266
Treatments
Experimental: Tislelizumab combined with GX
Patients will receive tislelizumab combined with GX regimen: Tislelizumab:200mg vgtt,q3w;treatment until disease progression, patients withdrawal of informed, or intolerable toxicity.~Gemcitabine:1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles. Capecitabine: 1000mg/m2, bid,po, d1-14, q3; treatment until disease progression, patients withdrawal of informed, or intolerable toxicity.
Experimental: Tislelizumab combined with GP
Patients will receive tislelizumab combined with GX regimen: Tislelizumab: 200mg vgtt,q3w;treatment until disease progression, patients withdrawal of informed, or intolerable toxicity.~Gemcitabine: 1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles; Cisplatin: 80mg/m2, ivgtt, d1 (high-dose cisplatin antiemetic and hydration regimen), q3w,repeat 4 \~ 6 cycles.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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