This prospective, phase II, multicenter, randomized controlled study aims to compare the complete response rate and long-term survival outcomes of two-cycle and three-cycle induction therapy with modified TPF regimens combined with camrelizumab in patients with locally advanced nasopharyngeal carcinoma.
Age: 18-65 years old;
Pathologically (including histology or cytology) confirmed nasopharyngeal carcinoma patients, with clinical staging T1-4N2-3M0 (according to the UICC/AJCC TNM staging system, 8th edition);
No prior systemic treatment (surgery, radiotherapy, chemotherapy, etc.);
At least one measurable lesion on imaging (as per RECIST criteria version 1.1);
Active, known, or suspected autoimmune disease;
Patients with hypertension that cannot be controlled to normal range despite antihypertensive medication (systolic BP >160 mmHg, diastolic BP >90 mmHg);
History of hereditary bleeding tendency or coagulation dysfunction. Any clinically significant bleeding symptoms within 12 weeks prior to screening, or cumulative bleeding over 50 ml in 24 hours;
Unwell-controlled cardiac clinical symptoms or diseases;
Parallel
Two-cycle induction chemotherapy + immunotherapy
DrugTwo cycles of nab-paclitaxel at 260 mg/m2 on day 1, cisplatin at 25 mg/m2 from days 1 to 3, and oral S1 twice daily from days 1 to 14 (40 mg twice daily on patients with a body surface area \[BSA\] less than 1.25 m2, 50 mg twice daily for patients with a BSA between 1.25 and 1.5 m2, and 60 mg twice daily for patients with a BSA \>1.5 m2). Camrelizumab was administered intravenously at a dose of 200 mg on the first day of each cycle.
Three-cycle induction chemotherapy + immunotherapy
DrugThree cycles of nab-paclitaxel at 260 mg/m2 on day 1, cisplatin at 25 mg/m2 from days 1 to 3, and oral S1 twice daily from days 1 to 14 (40 mg twice daily on patients with a body surface area \[BSA\] less than 1.25 m2, 50 mg twice daily for patients with a BSA between 1.25 and 1.5 m2, and 60 mg twice daily for patients with a BSA \>1.5 m2). Camrelizumab was administered intravenously at a dose of 200 mg on the first day of each cycle.
Complete response
Complete Remission after induction therapy means that all detectable signs of the tumor have disappeared, including all measurable and assessable diseases. This includes the absence of any tumor lesions in imaging studies.
Progression-free survival
Progression-free survival was measured from the day of the NPC diagnosis until disease recurrence and death from any cause.
Overall survival
Overall survival was measured from the day of the NPC diagnosis until death due to any cause.
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