About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Two-cycle induction chemotherapy + immunotherapy
  • Three-cycle induction chemotherapy + immunotherapy

Treatment groups

208 Participants
are divided into 2 treatment groups

Locations

3
The First Affiliated Hospital of Xiamen University361003, XiamenFujian, China
Zhangzhou Affiliated Hospital of Fujian Medical University363099, ZhangzhouFujian, China
Hainan General Hospital570311, HaikouHainan, China

Sponsors and collaborators

The First Affiliated Hospital of Xiamen University

Lead sponsor