Rituximab Plus Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Head and Neck Squamous Carcinoma Clinical Trial

Official title: A Phase I Pilot Study of B Cell Depletion With Rituximab Following by Chemotherapy With Cisplatin Plus Gemcitabine for Recurrent Unresectable or Metastatic Head and Neck Cancer Squamous Cell Carcinoma Patients.

Status Completed

Clinical Trial Summary

Head and neck squamous cell carcinoma (HNSCC) is an important disease with the incidence of 6th all over the world. In Taiwan it is the fifth of male cancer mortality. Most of the patients were middle age and the impact for economy and society was incredible. For recurrent or metastatic HNSCC, the average life span was around 4-6 months. Most patients just can receive chemotherapy. However the chemotherapy can't have any survival benefit. Recently a study showed the Cetuximab plus chemotherapy with cisplatin and 5-fluorouracil had survival benefit in the recurrent or metastatic HNSCC. However in Taiwan, the cetuximab can't be given by health insurance for the patients of the situation.

A lot of investigations recently showed the B lymphocytes got involvements in the squamous cell carcinoma carcinogenesis and tumor progression. In addition the B cell will influence the tumor associated macrophages and myeloid derived suppressor cells. Those immune cells could decrease the affect of chemotherapy and radiotherapy. Thus the B cell depletion has the possibility to develop a new treatment policy. Therefore investigators create a pilot clinical trial using Rituximab plus chemotherapy with cisplatin and gemcitabine for recurrent or metastatic HNSCC.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Carcinoma
• Squamous Cell Carcinoma of Head and Neck

• NCT number: NCT04361409
• Study type: Interventional
• Source: China Medical University Hospital
• Status: Completed
• Phase: Phase 1
• Start date: May 2013
• Completion date: January 2017