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

Recruiting now · Phase 2

Conditions studied: Nasopharyngeal Neoplasms, PD-1 Inhibitor, Induction Therapy, Complete Response, Chemotherapy

In brief

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.

Key facts

Study ID

NCT06811844

Run by

The First Affiliated Hospital of Xiamen University

People needed

208

Starts

2025-02-25

Expected to finish

2029-12-31

Last updated by the study team

2025-07-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (enrolling)
• Zhangzhou Affiliated Hospital of Fujian Medical University — Zhangzhou, Fujian, China (enrolling)
• Hainan General Hospital — Haikou, Hainan, China (enrolling)

Full record on ClinicalTrials.gov

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