Nimotuzumab for Recurrent Nasopharyngeal Carcinoma

Phase 2

• Conditions: Recurrent Nasopharyngeal Carcinoma
• Interventions: Drug: Nimotuzumab

• Registration Number: NCT03666221
• Lead Sponsor: Fujian Cancer Hospital

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 Timeline

• Study Start: 2014-11-01
• Status Verified: 2018-09
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-10
• Last Update Submitted: 2018-09-10
• Study First Posted: 2018-09-11
• Last Update Posted: 2018-09-11
• Primary Completion: 2020-04-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab plus IMRT	Nimotuzumab	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.

Primary Outcome Measures

Name	Time	Method
Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients	Three month after patients subject to the treatment	The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.
Toxicity of this combined treatment for recurrent NPC patients	Three month after patients subject to the treatment	Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.Toxicity Criteria for Adverse Events version 3.0

Secondary Outcome Measures

Name	Time	Method
Local Progression free survival	Three years
Disease-free survival	Three years	Defined as the time in month from all treatment were finished to the date of disease progress is observed.
Overall survival	Three years	Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit.

Trial Locations

Locations (1)

Department of radiation oncology, Fujian cancer hospital; 🇨🇳 Fuzhou, Fujian, China