Nasopharyngeal Carcinoma
Conditions
Brief summary
This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs.
Detailed description
This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs. Subjects who meet the inclusion/exclusion criteria are administered of Nimotuzumab based on medication instructions or adjusted by clinicians according to the treatment. In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of Nimotuzumab is stopped.
Interventions
patients receive nimotuzumab injection for 200mg/w,intravenous infusion over 60 minutes.Doctor adjust the dosage of nimotuzumab and choose other treatment options according to the actual situation of patients.
Sponsors
Biotech Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients with histologically or cytologically confirmed nasopharyngeal carcinoma 2. Sex and age without limiting 3. Treatment without limiting 4. Subjects with reproductive potential (males and females) willing to use reliable means of contraception 5. Able and willing to give written informed consent and comply with the requirements of the study protocol
Exclusion criteria
1. Patients with severe allergies or idiosyncratic constitution 2. Women who are pregnant (determined by urine pregnancy test)or breast feeding 3. Any other severe complications or functional disorder of organ systems, which will affect the evaluation of safety of patients or will interfere with the test drug according to the researcher's point of view
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03) | up to 30 months |
Countries
China
Contacts
Primary ContactLi gao, PhD
Outcome results
None listed