Tislelizumab Plus GX Versus Tislelizumab Plus GP in the Treatment of R/M NPC

NCT06177301 | Recruiting Phase 3

• 1 other identifier: FUSCC-NC-001
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.

  up to approximately 3 years

Secondary Outcomes (1)

• 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.

  up to approximately 3 years

Other Outcomes (3)

• 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.

  up to approximately 3 years

• 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.

  up to approximately 3 years

• 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.

  up to approximately 3 years

Study Arms (2)

Tislelizumab combined with GX

EXPERIMENTAL

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.

Drug: Tislelizumab combined with GX

Tislelizumab combined with GP

EXPERIMENTAL

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.

Drug: Tislelizumab combined with GP

Interventions

Tislelizumab combined with GX DRUG

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.

Tislelizumab combined with GX

Tislelizumab combined with GP DRUG

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.

Tislelizumab combined with GP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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;

You may not qualify 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, unstable angina, acute myocardial infarction within 6 months before screening, congestive heart failure, Q-Tc interval greater than 500ms;
• 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;
• 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) ;
• 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;
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Dongmei Ji, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongmei Ji, M.D

CONTACT

021-64175590; jidongmei2000@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

CN (1)