This is a prospective, open-label, multicenter, single-arm clinical study. A total of 30 patients with locally advanced nasopharyngeal carcinoma who have not received prior systemic treatment are planned to be enrolled at three centers. After enrollment, the patients will receive induction therapy with Iparomlimab/Tuvorlimab(QL-1706) in combination with a modified TPF regimen, followed by concurrent chemoradiotherapy with cisplatin according to the standards of clinical practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Induction therapy: Albumin-bound paclitaxel 260 mg/m² + cisplatin 75 mg/m² (divided on days 1 - 3) + S1 calculated according to body surface area, taken twice daily (days 1 - 14) + Iparomlimab/Tuvorlimab(QL-1706) 5 mg/kg (day 1). One cycle lasts for 21 days, and the treatment continues for three consecutive cycles. Concurrent chemotherapy: Cisplatin 80 mg/m², divided on days 1 - 3. One cycle lasts for 21 days, and the treatment continues for two consecutive cycles. Radiotherapy regimen: Whole-course IMRT.
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGComplete response rates after induction therapy
Higher scores mean a better outcome.
Time frame: From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).
ORR
Higher scores mean a better outcome.
Time frame: From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Higher scores mean a worse outcome.
Time frame: From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).
PFS
Higher scores mean a better outcome.
Time frame: From the time of enrollment until two years after the completion of the treatment.
OS
Higher scores mean a better outcome.
Time frame: From the time of enrollment until two years after the completion of the treatment
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