Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab f… (NCT06811844) | Clinical Trial Compass
RecruitingPhase 2
Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for LANPC
China208 participantsStarted 2025-02-25
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 …
What they're measuring
1
Complete response
Timeframe: At the end of Cycle 2 or Cycle 3 (each cycle is 21 days)
Trial details
NCT IDNCT06811844
SponsorThe First Affiliated Hospital of Xiamen University