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Clinical Trials in China / NCT07248696
Active, not recruiting Not applicable

Tislelizumab Plus Chemotherapy With Response-Adapted Radiotherapy for de Novo Metastatic Nasopharyngeal Carcinoma: A Prospective, Phase II Trial

NCT07248696 · tracked via the Priya Life Science China tracker
Sponsor
Chongqing University Cancer Hospital
Phase
Not applicable
Started
2025-10-04
Last updated
2025-11-25

Condition(s) studied

Nasopharyngeal Cancinoma (NPC)

Investigational drug(s) / intervention(s)

response-adapted radiotherapy

response-adapted radiotherapy: Induction Treatment Regimen: • Tislelizumab+Gemcitabine+Cisplatin for 4-6 cycles . Response-Adapted Radiotherapy: * Patients achieving CR after induction therapy require no radiotherapy. * Patients achieving PR after induction therapy: Radiotherapy (55 Gy/20 fractions, 5 fractions per week, over 4 weeks) to the residual primary nasopharyngeal lesion and metastatic cervical lymph nodes. Radiotherapy for metastatic lesions concurrently or sequentially with locoregional radiotherapy. Immunotherapy Regimen: maintenance therapy with tislelizumab monotherapycontinues until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first. The total treatment duration shall not exceed 2 years

Study summary

This study is aimed to evaluate the efficacy and safety of tislelizumab combined with chemotherapy and response-adapted radiotherapy in patients with de novo metastatic nasopharyngeal carcinoma

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-70 years. 2. Newly diagnosed nasopharyngeal carcinoma with pathological confirmation of non-keratinizing carcinoma (WHO type II or III). 3. Stage IV (T1-4N0-3M1a and M1b) according to the AJCC/UICC 9th edition clinical staging system for NPC. 4. Achieved complete response (CR) or partial response (PR) by imaging evaluation after 4-6 cycles of GP chemotherapy combined with tislelizumab. 5. ECOG performance status: 0-1. 6. Adequate organ function. Exclusion Criteria: 1. Recurrent or metastatic nasopharyngeal carcinoma after radical treatment. 2. Other malignancies diagnosed or treated within the past 5 years (except basal cell carcinoma, cervical carcinoma in situ, and superficial bladder tumors). 3. Previous treatment with immune checkpoint inhibitors. 4. Pregnancy or lactation (consider pregnancy testing for women of childbearing age and emphasize effective contraception during treatment). 5. Active or history of autoimmune diseases. 6. Concurrent medical condition requiring the use of immunosuppressive medications. 7. Active hepatitis B or C infection.

Primary outcome measure(s)

  • PFS — 1-year
    PFS is defined as the time from the initiation of treatment until the first occurrence of locoregional progression, distant metastatic progression, or death from any cause, whichever comes first.

Trial sites (1)

FacilityCityRegionStatus
Chongqing University Cancer Hospital Chongqing Chongqing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07248696 on ClinicalTrials.gov ↗ ← All trials in China