Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biotech Pharmaceutical Co., Ltd. | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.
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 dosage is 180mg/m2; Nimotuzumab treatment be divided 3 levels:200mg/w,400mg/w,600mg/w,weekly.The patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks,when the total result is the CR or PR, the result of the 6th and the 12th week should be compared.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab and chemotherapy | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated. | within study period |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the complete response rate, partial rate, disease response rate, disease control rate in the patients subject to treatment | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shen Lin | Contact | 86-01-88196561 |
| Name | Affiliation | Role |
|---|---|---|
| Shen Lin | Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | 510060 | China |
Not provided
| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Peking University, School of Oncology, Beijing Cancer Hospital & Institute | Recruiting | Beijing | China |
|
| China People's Liberation Army (PLA)81 Hospital | Not yet recruiting | Nanjing | China |
|