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

Comparison of Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for Locally Advanced Nasopharyngeal Carcinoma: A Prospective, Phase II, Multicenter, Randomized Controlled Study

This study is testing whether two cycles of chemotherapy combined with immunotherapy can help people with advanced nasopharyngeal cancer just as much as three cycles, but with fewer side effects.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (Academic / other)
• Drugs / interventions: chemotherapy, radiation, camrelizumab, immunotherapy
• Locations: 3 sites (Xiamen, Fujian and 2 other locations)
• Trial ID: NCT06811844 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with pathologically confirmed locally advanced nasopharyngeal carcinoma and no prior systemic treatment.

Not a fit: Patients with active autoimmune diseases or uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less toxic treatment option for patients with locally advanced nasopharyngeal carcinoma.

How similar studies have performed: Previous studies have indicated that reducing the number of chemotherapy cycles may not compromise survival, suggesting this approach could be promising.

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.

Where this trial is running

Xiamen, Fujian and 2 other locations

• 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

Conditions Nasopharyngeal Neoplasms; PD-1 Inhibitor; Induction Therapy; Complete Response; Chemotherapy