Status:
UNKNOWN
Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma
Lead Sponsor:
Peking University
Collaborating Sponsors:
Chinese PLA General Hospital
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 EG...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03400592
Start Date
June 1 2015
End Date
June 1 2018
Last Update
January 17 2018
Active Locations (1)
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1
Peking cancer hospital
Beijing, Beijing Municipality, China, 100142