Clinical trial NCT03400592: Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasms
Keywords: gastric adenocarcinoma
EGFR
Irinotecan
Nimotuzumab
biomarker
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2018-01-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response rate
timeFrame: 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 outcomes:
measure: Overall survival
timeFrame: 3 years after first enrollment
measure: Progression free survival
timeFrame: 3 years after first enrollment
measure: Disease control rate
timeFrame: 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
measure: Safety
timeFrame: 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
measure: Potential predictive biomarkers of nimotuzumab
timeFrame: 3 years after first enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking cancer hospital
state: Beijing
Study officials:
References: