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

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat patients with locally advanced nasopharyngeal carcinoma, a type of cancer in the area behind the nose. Researchers want to see if giving two or three cycles of a specific combination of chemotherapy (known as modified TPF) along with a drug called camrelizumab can lead to better results in shrinking tumors and improving survival rates. This trial is currently recruiting participants aged 18 to 65 who have been diagnosed with this type of cancer but have not received any previous treatments.

If you or a loved one is interested in participating, you would need to have a confirmed diagnosis of nasopharyngeal carcinoma and meet several health criteria. Participants can expect to receive either two or three cycles of the treatment and will be monitored closely for their response to the therapy. It's important to note that there are specific health conditions that could prevent someone from joining the study, such as uncontrolled autoimmune diseases or certain heart and lung issues. Overall, this trial aims to find a more effective treatment approach for this challenging cancer.

Gender

ALL

Eligibility criteria

• 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.