Nimotuzumab for Recurrent Nasopharyngeal Carcinoma

NCT ID: NCT03666221

Last Updated: 2018-09-11

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

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-01

Study Completion Date

2022-11-01

Brief Summary

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The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with intensity modulated radiation therapy(IMRT) in patients with recurrent nasopharyngeal cancer.

Detailed Description

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The clinical efficacy of Nimotuzumab combined with radiotherapy has been shown in advanced nasopharyngeal cancer, which was significantly higher than radiotherapy alone. The efficacy of radiotherapy combined with Nimotuzumab has not been confirmed in recurrent nasopharyngeal cancer.In this study, Phase II clinical trials were performed. The patients were treated with Nimotuzumab which were used concurrently with IMRT. The efficacy and toxicity will be assessed.

Conditions

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Recurrent 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 plus IMRT

Patients with recurrent nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent intensity modulated radiation therapy(IMRT) , folowing weekly nimotuzumab (200 mg/week) for totally 8 weeks concurrent with IMRT.

Group Type EXPERIMENTAL

Nimotuzumab

Intervention Type DRUG

Drug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy

Interventions

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Nimotuzumab

Drug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy

Intervention Type DRUG

Other Intervention Names

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Radiation

Eligibility Criteria

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Inclusion Criteria

1. Patients with recurrent tumor in nasopharynx with or without relapse cervical lymph nodes more than 6 months after initial radical treatment.
2. Recurrent nasopharyngeal cancer was confirmed by pathology, marginal recurrence can be diagnosed by imaging examinations.
3. Age 18-70.
4. At least one of the tumor lesions measurable.
5. Functional Status: PS (ECOG) \> 0-1.
6. Normal Bone Marrow Function: White blood cell count \> 4×109/L, hemoglobin \>90g/L, and platelet count \>100×109/L.
7. Normal Hepatic and Renal Function: Alanine Tminotransferase (ALT)/Aspartate Aminotransferase (AST) \< 2.5 times the upper limit of normal (ULN), while total bilirubin (T-Bil) \< 1.5 x ULN and serum creatinine \< 1.5 x ULN.
8. Life expectancy of more than 6 months.
9. All the patients signed the informed consent.
10. Follow up regularly and comply with test requirements.

Exclusion Criteria

1. Patients with recurrent cervical lymph nodes alone.
2. Evidence of distant metastasis
3. The relapse tumor has been treated with chemotherapy, radiotherapy, surgery, immunotherapy and other anti-tumor therapy.
4. Creatinine clearance \< 30ml/min
5. Has received epidermal growth factor targeting therapy.
6. Second malignancy within 5 years(except of Non-melanoma Skin Cancer or carcinoma in situ of cervix).
7. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.
8. Active systemic infection.
9. History of Serious lung or heart disease.
10. Drug or alcohol addiction.
11. Persons without capacity for civil conduct or persons with limited capacity for civil conduct.
12. The patient has physical or mental disorders and is believed to be unable to fully or fully understand the possible complications of the study.
13. To receive chronic systemic immunotherapy or hormone therapy other than this study.
14. Women who are pregnant or breast feeding
15. Participation in other drugs clinical trials within 1 month.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role collaborator

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of radiation oncology, Fujian cancer hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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SHAOJUN LIN, Dr.

Role: CONTACT

0591-62752225

Facility Contacts

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SHAOJUN LIN, master

Role: primary

0086-0591-62752225

Other Identifiers

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NPC001.2

Identifier Type: -

Identifier Source: org_study_id

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