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

Summary

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

Inclusion Criteria:

* 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);
* ECOG Performance Status (PS): 0-1;
* Expected survival ≥3 months;
* Male subjects and women of childbearing potential must use contraception from the first dose of study medication until 24 weeks after the last dose of study medication;
* Normal major organ function, with basic normal results in hematology, biochemistry, and coagulation tests;
* The investigator believes that the treatment will provide a survival benefit.

Exclusion Criteria:

* 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;
* Interstitial lung disease, drug-induced pneumonia, steroid-treated radiation pneumonitis, active pneumonia with symptoms, or severe pulmonary dysfunction;
* Active hepatitis B (HBV DNA ≥2000 IU/mL or 10\^4 copies/mL), hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection of the assay);
* Allergy to any of the study drugs;
* Pregnant or breastfeeding women;
* Any other factors that, in the investigator's judgment, may cause premature termination of the study.

Conditions6

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