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

Peking University55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stomach Neoplasms

Interventions

IrinotecanDRUG

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

nimotuzumabDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking cancer hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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