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Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma (NIEGA)

Primary Purpose

Stomach Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Irinotecan
nimotuzumab
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring gastric adenocarcinoma, EGFR, Irinotecan, Nimotuzumab, biomarker

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria:
  • Willing to sign ICF
  • Above 18 years
  • KPS score≥70
  • Expected survival time more than 90 days
  • Subjects with EGFR overexpression (2+ or 3+ in IHC)
  • With target lesions in spiral CT or MRI examination within 30 days
  • Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent ,platinum agent and Paclitaxel agent.
  • Lab test of baseline meet following criteria
  • Hemoglobin higher than 9.0g/dL
  • Neutrophil higher than 1,500/mm3
  • PLT higher than 10.0 104/mm3
  • Bilirubin lower than 1.5 times of upper limit of normal range
  • AST,ALT,ALP lower than 2.5 times of upper limit of normal range
  • Creatinine lower than upper limit of normal range
  • When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range

Exclusion Criteria:

  • Patients who have received irinotecan
  • Patients who are allergic to irinotecan or nimotuzumab.
  • Other active malignancy within the last 5 years
  • Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
  • Investigator judge not eligible to this trial

Sites / Locations

  • Peking cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

irinotecan and nimotuzumab

Arm Description

Administration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly

Outcomes

Primary Outcome Measures

Objective response rate
CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1.Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response

Secondary Outcome Measures

Overall survival
Overall survival is defined as the time from the date of enrollment to the date of the death from any cause.
Progression free survival
Progression Free Survival is defined as the time from the date of enrollment to the date of progression or death from any cause
Disease control rate
Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response
Safety
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Potential predictive biomarkers of nimotuzumab

Full Information

First Posted
October 10, 2015
Last Updated
January 9, 2018
Sponsor
Peking University
Collaborators
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03400592
Brief Title
Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma
Acronym
NIEGA
Official Title
Multi-center Phase II Trial of Nimotuzumab Plus Irinotecan in Patients With High EGFR Expression After Failure of First-line Treatment in Recurrent or Metastatic Gastric Adenocarcinoma（NIEGA）
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer.
Detailed Description
The sample size was calculated using Simon's 2-stage design. The first stage require at least 4 or more out of 19 patients to have a confirmed partial or complete response (assuming P1 = 0.30, P0 = 0.10, with alpha = 0.05 and beta = 0.2) before proceeding to the second stage, in which additional 36 patients were needed. If a total of 15 or more patients achieve a confirmed objective response, then the primary end-point would have been met. The predicted response rate in this study is at least 30%. Blood and tissue samples are required to collect at baseline, response and disease progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
gastric adenocarcinoma, EGFR, Irinotecan, Nimotuzumab, biomarker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
irinotecan and nimotuzumab
Arm Type
Experimental
Arm Description
Administration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient
Intervention Type
Drug
Intervention Name(s)
nimotuzumab
Intervention Description
400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient
Primary Outcome Measure Information:
Title
Objective response rate
Description
CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1.Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response
Time Frame
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is defined as the time from the date of enrollment to the date of the death from any cause.
Time Frame
3 years after first enrollment
Title
Progression free survival
Description
Progression Free Survival is defined as the time from the date of enrollment to the date of progression or death from any cause
Time Frame
3 years after first enrollment
Title
Disease control rate
Description
Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response
Time Frame
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Title
Safety
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Title
Potential predictive biomarkers of nimotuzumab
Time Frame
3 years after first enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria: Willing to sign ICF Above 18 years KPS score≥70 Expected survival time more than 90 days Subjects with EGFR overexpression (2+ or 3+ in IHC) With target lesions in spiral CT or MRI examination within 30 days Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent ,platinum agent and Paclitaxel agent. Lab test of baseline meet following criteria Hemoglobin higher than 9.0g/dL Neutrophil higher than 1,500/mm3 PLT higher than 10.0 104/mm3 Bilirubin lower than 1.5 times of upper limit of normal range AST,ALT,ALP lower than 2.5 times of upper limit of normal range Creatinine lower than upper limit of normal range When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range Exclusion Criteria: Patients who have received irinotecan Patients who are allergic to irinotecan or nimotuzumab. Other active malignancy within the last 5 years Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures Investigator judge not eligible to this trial
Facility Information:
Facility Name
Peking cancer hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lin shen, MD. PhD
Phone
(86)10-88196561
Email
linshenpku@163.com
First Name & Middle Initial & Last Name & Degree
jifang gong, MD. PhD
Phone
(86)10-88196561
Email
gongjifang@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma

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