Phase II study of nimotuzumab (TheraCim-hR3) concurrent with cisplatin/radiotherapy in patients with locally advanced head and neck squamous cell carcinoma

Head Neck. 2021 May;43(5):1641-1651. doi: 10.1002/hed.26635. Epub 2021 Feb 5.


Background: The efficacy of a combination of nimotuzumab, a humanized monoclonal antibody to the epidermal growth factor receptor, with chemoradiation in locally advanced head and neck squamous cell carcinoma (HNSCC) was evaluated in a phase II study.

Methods: Patients with stage III/IV HNSCC received 3-weekly cisplatin 100 mg/m2 for three cycles and weekly nimotuzumab 200 mg for 8 weeks concurrently with radiotherapy. Primary endpoint was best overall response (BOR) and secondary endpoint was progression-free survival (PFS).

Results: Thirty-seven patients were included; the majority were Chinese (76%), male (89%), and had stage IVA/IVB HNSCC (92%). BOR of complete and partial response was seen in 22/37 (59%) and 10/37 (27%) patients, respectively. Median PFS was 17.5 months (95% CI: 11.1-54.5) and 3-year PFS was 40.4% (95% CI: 24.3-55.9). The frequency and type of adverse events observed were similar to standard chemoradiation.

Conclusion: The combination of nimotuzumab with cisplatin and radiotherapy was safe and achieved high response rates in HNSCC.

Keywords: HNSCC; cisplatin; nimotuzumab; radiotherapy.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Carcinoma, Squamous Cell* / drug therapy
  • Chemoradiotherapy
  • Cisplatin / therapeutic use
  • Female
  • Head and Neck Neoplasms* / therapy
  • Humans
  • Male
  • Squamous Cell Carcinoma of Head and Neck / therapy


  • Antibodies, Monoclonal, Humanized
  • nimotuzumab
  • Cisplatin