Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma

Study Overview
=================
Brief Summary
-----------------
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. However, whether maintenance therapy of nimotuzumab provides benefit to advanced esophageal cancer patients is not known.

Detailed Description
-----------------
We design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.

Official Title
-----------------
Phase II Study of Maintenance Treatment of Nimotuzumab Versus No Maintenance for Advanced Esophageal Carcinoma

Conditions
-----------------
Stage IV Esophageal Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Nimotuzumab
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology. The sample size estimate: 20 cases per arm. Males or females aged ≥18 years, < 75 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks. Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug. 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. Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment. 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
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Nimotuzumab | Drug: Nimotuzumab<br>* 400mg Q2W intravenously<br>* Other names: Anti epidermal growth factor receptor antibody h-R3;|
| Placebo Comparator: Arm B<br>Placebo (normal saline) | Drug: Placebo<br>* Normal saline<br>* Other names: Normal saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | 6 months | 
| Overall survival (OS) |  | 12 months | 
| Disease control rate (DCR) |  | 12 months |