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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
PFS
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.
Time frame: 1-year
OS
Time frame: 1-year
Local Regional Control
Time frame: 1-year
Distant Metastasis Control
Time frame: 1-year
ORR
Time frame: 1-year
DoR
Time frame: 1-year
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