Brief Title
Nimotuzumab for Recurrent Nasopharyngeal Carcinoma
Official Title
An Open,Multicenter,Phase II Trial of Intensity Modulated Radiation Therapy Combined With Concurrent Nimotuzumab in Patient With Recurrent Nasopharyngeal Carcinoma
Brief Summary
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients
Secondary Outcome
Local Progression free survival
Condition
Recurrent Nasopharyngeal Carcinoma
Intervention
Nimotuzumab
Study Arms / Comparison Groups
Nimotuzumab plus IMRT
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
67
Start Date
November 1, 2014
Completion Date
November 1, 2022
Primary Completion Date
April 1, 2020
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, 0591-62752225, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03666221
Organization ID
NPC001.2
Responsible Party
Sponsor
Study Sponsor
Fujian Cancer Hospital
Collaborators
Sun Yat-sen University
Study Sponsor
, ,
Verification Date
September 2018