Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nimotuzumab Injection

200mg,Once a week，Intravenous infusion over 60 minutes

Group Type EXPERIMENTAL

Nimotuzumab Injection

Intervention Type DRUG

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.

Interventions

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Nimotuzumab Injection

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.

Intervention Type DRUG

Other Intervention Names

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Taixinsheng

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No