Overview

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

Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University
Collaborator:
Chinese PLA General Hospital
Treatments:
Camptothecin
Irinotecan
Nimotuzumab
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 scoreā‰„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