Neoadjuvant Chemotherapy of Nimotuzumab Plus Nab-Paclitaxel in Squamous Cell Carcinoma of Esophagus

NCT ID: NCT02041819

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-01-31

Brief Summary

Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR),has been shown to be effective and safe in some studies with head-neck cancers.Nab-paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel.However,the safety and efficacy of Nimotuzumab plus nab-paclitaxel regimen is uncertain in neoadjuvant therapy in esophageal cancer.The investigators then initiated a phase II clinical trial with Nimotuzumab plus Nab-paclitaxel/cisplatin as the neoadjuvant chemotherapy in patients with locally advanced esophageal squamous cell carcinoma to observe the efficacy and safety of the combination.

Detailed Description

In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin as perioperative therapy for patients with resectable esophageal squamous cell carcinoma.

Conditions

Squamous Cell Carcinoma of Esophagus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nimotuzumab nab-paclitaxel 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.

Nab-paclitaxel: 125mg/m2,IV on days 1,8,22,29.

patients will receive radical operation 4-6 weeks after Neoadjuvant therapy.

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

Nimotuzumab: 200mg,IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36).

Interventions

Nimotuzumab

Nimotuzumab: 200mg,IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36).

Intervention Type: DRUG

Other Intervention Names

nimo

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
• Locally advanced disease that is technically operable with curative intent (R0)
• T3, N0 OR T1-3, N+ OR T4, Nx
• No T1-2, N0
• No inoperable T4 (unequivocal organ involvement)
• No distant metastasis, including M1a lymph node status
• Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
• No carcinoma of the cervical esophagus
• Obstructive tumors allowed

Exclusion Criteria

• Not suitable to surgery
• cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
• early Esophageal Carcinoma(Stage I)
• complete esophageal obstruction，Esophageal perforation or hematemesis
• other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
• pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
• Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
• History of serious allergic or castor oil allergy
• Patients who are not suitable to participate in the trial according to researchers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Qiong Zhao

Chief of Department of Thoracic Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiong Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Zhejiang University

Locations

The first affiliated hospital, Zhejiang University

Zhejiang, Zhejiang, China

Countries

China

Other Identifiers

ZYTOP1405

Identifier Type: -

Identifier Source: org_study_id