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Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

NCT01688700 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-09-20

No results posted yet for this study

Summary

A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity

Conditions

  • Esophageal Squamous Cell Carcinoma Resectable

Interventions

DRUG

Nimotuzumab combined with paclitaxel and cisplatin

Nimotuzumab: 200mg, IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36). Cisplatin: 75mg/m2,IV on days 1，22 paclitaxel: 90mg/m2, IV on days 1,8,22,29. patients will receive radical operation 4-6 weeks after Neoadjuvant therapy.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-09-30
Completion
2017-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01688700 on ClinicalTrials.gov