Status:
COMPLETED
Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer
Lead Sponsor:
Biotech Pharmaceutical Co., Ltd.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been sh...
Detailed Description
Nimotuzumab and Irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment. Irinotecan will be administered once every 14 days, the ...
Eligibility Criteria
Inclusion
- Informed consent form signed before performing any of the study's specific procedures.
- ECOG performance status 0-2.
- Age \> 18，both genders.
- Metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer
- Disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment
- At least 1 measurable lesions ,( longest diameter≥ 1 cm by spiral computed tomography (CT) scan or MRI)
- Life expectancy more than 3 months.
- K-ras is wild type
- Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
- Liver metastasis, lesions smaller than 50% of the liver; Lung metastasis, lesions smaller than 30% of the lung
- Haemoglobin≥90g/L , granulocyte≥1.5×109/L ,WBC ≥3×109/L, platelet count≥100×109/L
- TBIL≤ 1.5 x ULN ,ALK≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis），AST and ALT≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis）,Creatinine ≤ 1.5 x ULN
- No brain metastasis
Exclusion
- Previous radiotherapy at lesions within three months
- Other first line chemo-agents treatment except oxaliplatin ± fluorouracil
- Received other anti EGFR monoclonal antibody treatment
- Complete or incomplete intestinal obstruction
- Participation in other interventional clinical trials within 1 month
- Psychiatric disease affected cognitive ability, including brain metastasis
- Peripheral neuropathy lesion is more than I stage.
- History of serious allergic or allergy
- Pregnant or breast-feeding women
- Patients with the history of Serious lung or hear disease
- Other malignant tumor
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05278728
Start Date
July 1 2009
End Date
December 1 2013
Last Update
February 7 2025
Active Locations (2)
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1
China People's Liberation Army (PLA)81 Hospital
Nanjing, Jiangsu, China
2
Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Beijing, China, 100036