Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
48 participants
INTERVENTIONAL
2009-06-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Nimotuzumab and chemotherapy
Experimental: Nimotuzumab and Irinotecan
the chemotherapy treatment: Irinotecan (180 mg/m2/time, 1 time/14 days, until disease progression)
the nimotuzumab treatment: 3 levels (200 mg/w, 400 mg/w, 600 mg/w, weekly, until disease progression)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Biotech Pharmaceutical Co., Ltd.
OTHER
Peking University
OTHER
Responsible Party
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Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Principal Investigators
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Shen Lin
Role: PRINCIPAL_INVESTIGATOR
Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Locations
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Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Beijing, , China
China People's Liberation Army (PLA)81 Hospital
Nanjing, , China
Countries
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Central Contacts
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Shen Lin
Role: CONTACT
Facility Contacts
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Other Identifiers
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BT-CRC-T
Identifier Type: -
Identifier Source: org_study_id
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