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

Stomach Neoplasms Clinical Trial

— 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）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03400592
• Other study ID #: NIEGA
• Status: Recruiting
• Phase: Phase 2
• First received: October 10, 2015
• Last updated: January 9, 2018
• Start date: June 2015
• Est. completion date: June 2018

Study information

• Verified date: January 2018
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Stomach Neoplasms

Intervention

Drug:
• Irinotecan
180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient
• nimotuzumab
400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient

Locations

Country	Name	City	State
China	Peking cancer hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Overall survival	Overall survival is defined as the time from the date of enrollment to the date of the death from any cause.	3 years after first enrollment
Secondary	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	3 years after first enrollment
Secondary	Disease control rate	Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response	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	Safety	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	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	Potential predictive biomarkers of nimotuzumab		3 years after first enrollment