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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Withdrawn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
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
January 10, 2014
Last Updated
March 4, 2015
Sponsor
Zhejiang University
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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
No

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
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.
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
No
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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