Back to resultsPhase IIa Study of Nimotuzumab to Treat Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring nimotuzumab, colorectal cancer, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- China People's Liberation Army (PLA)81 Hospital
- Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nimotuzumab and Irinotecan
Arm Description
Nimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles
Outcomes
Primary Outcome Measures
The rate of grade 3/4 toxicity
Secondary Outcome Measures
The maximum tolerated
The complete response rate
The partial rate
The disease control rate
Full Information
NCT ID
NCT05278728
First Posted
August 18, 2015
Last Updated
March 3, 2022
Sponsor
Biotech Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05278728
Brief Title
Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer
Official Title
Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotech Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
nimotuzumab, colorectal cancer, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nimotuzumab and Irinotecan
Arm Type
Experimental
Arm Description
Nimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
200,400,600 or 800mg weekly until progression or AEs
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles
Primary Outcome Measure Information:
Title
The rate of grade 3/4 toxicity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The maximum tolerated
Time Frame
3 months
Title
The complete response rate
Time Frame
3 months
Title
The partial rate
Time Frame
3 months
Title
The disease control rate
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen
Organizational Affiliation
Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
China People's Liberation Army (PLA)81 Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Peking University, School of Oncology, Beijing Cancer Hospital & Institute
City
Beijing
ZIP/Postal Code
100036
Country
China
12. IPD Sharing Statement
Learn more about this trial
Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer
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