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

Phase 2

Withdrawn

• Conditions: Stage IV Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Placebo; Drug: Nimotuzumab

• Registration Number: NCT02011594
• Lead Sponsor: Zhejiang University

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.

Study Timeline

• Study First Submitted: 2013-12-07
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-13
• Study Start: 2014-01
• Primary Completion: 2015-01
• Status Verified: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Placebo	Placebo (normal saline)
Arm A	Nimotuzumab	Nimotuzumab

Primary Outcome Measures

Name	Time	Method
PFS (Progression free survival)	12 months

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	6 months
Overall survival (OS)	12 months
Disease control rate (DCR)	12 months

Trial Locations

Locations (2)

Qiong Zhao; 🇨🇳 Hangzhou, Zhejiang, China

The first affiliated hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China