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

Primary Purpose

Squamous Cell Carcinoma of Esophagus

Status

Withdrawn

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nimotuzumab

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Esophagus focused on measuring Neoadjuvant chemotherapy, Nimotuzumab, Nab-Paclitaxel, Carcinoma of Esophagus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The first affiliated hospital, Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab nab-paclitaxel cisplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

response rate

pathological response rate and clinical response rate

Secondary Outcome Measures

Overall survival

Progression-free survival

Adverse events

Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0

Full Information

NCT ID

NCT02041819

First Posted

January 10, 2014

Last Updated

March 4, 2015

Sponsor

Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT02041819

Brief Title

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

Official Title

A Phase II Trial of Neoadjuvant Chemotherapy With Nimotuzumab Plus Nanoparticle Albumin-bound Paclitaxel and Cisplatin Followed by Surgery in Patients With Locally Advanced Squamous Cell Carcinoma of Esophagus

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Withdrawn

Why Stopped

No recruitment

Study Start Date

February 2014 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of Esophagus

Keywords

Neoadjuvant chemotherapy, Nimotuzumab, Nab-Paclitaxel, Carcinoma of Esophagus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nimotuzumab nab-paclitaxel cisplatin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nimotuzumab

Other Intervention Name(s)

nimo

Intervention Description

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

Primary Outcome Measure Information:

Title

response rate

Description

pathological response rate and clinical response rate

Time Frame

From date of treatment until the date of progression, assessed up to 2 months

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months

Title

Progression-free survival

Time Frame

Progression-free survival was measured from the date of treatment to the date of first evidence of relapse or death due to any cause,assessed up to 36 months

Title

Adverse events

Description

Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0

Time Frame

During the chemotherapy,an expected average of 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiong Zhao, MD

Organizational Affiliation

The First Affiliated Hospital, Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The first affiliated hospital, Zhejiang University

City

Zhejiang

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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