Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for LANPC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Xiamen University

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