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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
375mg/m2 on Day-14 and Day-7
70mg/m2 on Day1
1000mg/m2 on Day8
China medical University hospital
Taichung, Taiwan
feasibility of the combination of Rituximab with Gemcitabin/cisplatin in R/M HNSCC
Unexpected adverse event. An AE that is not listed in the drug's current labeling, or An AE that is more severe or more specific than indicated in the labeling.
Time frame: One week after Rituximab and chemotherapy administration.
Response rate
CT scan according to the RECIST 1.1 criteria.
Time frame: through study completion, an average of 1 years
progression survival
The time from the study registration date to the first day of disease progression at any site or of death by any cause.
Time frame: through study completion, an average of 6 months
Adverse event
Record adverse event
Time frame: through study completion, an average of 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.