Nasopharyngeal Cancinoma (NPC)
Conditions
Keywords
nasopharyngeal carcinoma, de novo metastatic, tislelizumab
Brief 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
Detailed description
This is a prospective phase II study that enrolled patients with previously untreated de novo metastatic nasopharyngeal carcinoma who achieved either a complete response (CR) or partial response (PR) after 4-6 cycles of treatment with gemcitabine plus cisplatin (GP regimen) chemotherapy combined with tislelizumab. Based on tumor response stratification, these patients received locoregional radiotherapy and radiotherapy for metastatic lesions, followed by sequential tislelizumab maintenance therapy.
Interventions
RADIATIONresponse-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
Sponsors
Chongqing University Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| OS | 1-year |
| Local Regional Control | 1-year |
| Distant Metastasis Control | 1-year |
| ORR | 1-year |
| DoR | 1-year |
Countries
China
Outcome results
None listed