Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma

Study Overview
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Brief Summary
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There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy.And,albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy,and with greater concentration in tumor tissue compared with normal tissues.So,The objective of this single-arm phase II trial was to evaluate the benefit of nimotuzumab plus nab-paclitaxel and cisplatin in patients with advanced esophageal carcinoma.

Detailed Description
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In the past decade, clinical trials have evaluated the role of chemotherapy, radiation, or both, for patients with advanced esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, Chemotherapy became one of the treatment strategies for advanced esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, the investigators conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin for patients with advanced esophageal squamous cell carcinoma.

Official Title
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Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma

Conditions
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Stage IV Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Nimotuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology. Males or females aged ≥18 years, < 75 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks. Adequate bone marrow, renal, and liver function are required. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. Exclusion Criteria: Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). Allergy to anti-EGFR antibody. Female subjects should not be pregnant or breast-feeding. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function: total bilirubin < 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nimotuzumab & nab-paclitaxel & cisplatin<br>Nimotuzumab: 200mg,IV once a week during chemotherapy. Nab-paclitaxel: 125mg/m2,(IV over 30 min) (days 1 and 8) on 21 day cycle Cisplatin: 75mg/m2,IV on 21 day cycle | Drug: Nimotuzumab<br>* Nimotuzumab: 200mg,IV once a week during chemotherapy.<br>* Other names: Anti epidermal growth factor receptor antibody h-R3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival(PFS) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | From date of treatment until the date of progression, assessed up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nimotuzumab, Nab-Paclitaxel, Carcinoma of Esophagus