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

Sponsor

Peking University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03400592

Collaborator

Chinese PLA General Hospital (Other)

Enrollment

Location

Arm

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms	Drug: Irinotecan Drug: nimotuzumab	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: irinotecan and nimotuzumab Administration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly	Drug: Irinotecan 180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient Drug: nimotuzumab 400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient

Arm

Intervention/Treatment

Experimental: irinotecan and nimotuzumab

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

Drug: Irinotecan

180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient

Drug: nimotuzumab

400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient

Outcome Measures

Primary Outcome Measures

Objective response rate [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]
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 [3 years after first enrollment]
Overall survival is defined as the time from the date of enrollment to the date of the death from any cause.
Progression free survival [3 years after first enrollment]
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 [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]
Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response
Safety [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]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Potential predictive biomarkers of nimotuzumab [3 years after first enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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