Comparing two and three cycles of chemotherapy with immunotherapy for advanced nasopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II, multicenter, randomized controlled study aims to evaluate the effectiveness of two-cycle versus three-cycle induction chemotherapy combined with camrelizumab in patients with locally advanced nasopharyngeal carcinoma. The study is based on previous findings suggesting that three cycles may not improve survival and could increase toxicity compared to two cycles. By incorporating immunotherapy into the treatment regimen, the investigators hypothesize that two cycles will yield similar tumor response rates with fewer adverse effects. The study will assess complete response rates and long-term survival outcomes in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting
• Zhangzhou Affiliated Hospital of Fujian Medical University
  Zhangzhou, Fujian, China Recruiting
• Hainan General Hospital
  Haikou, Hainan, China Recruiting

Study contacts

• Study coordinator: San-Gang Wu, MD
• Email: wusg@xmu.edu.cn
• Phone: 865922139531

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Interferon-gamma plus camrelizumab with chemotherapy before surgery for locally advanced esophageal squamous cell carcinoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.