A Phase 2 interventional study of Irinotecan and nimotuzumab in Stomach Neoplasms, sponsored by Peking University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-17.
Sponsored by Peking University · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Administration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
Drug: Irinotecan · Drug: nimotuzumab
180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient
400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient
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
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
Overall survival
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
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
Time frame: 3 years after first enrollment
Disease control rate
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
Safety
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
Potential predictive biomarkers of nimotuzumab
Time frame: 3 years after first enrollment
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Peking University