Colorectal CancerPhase 1/2NCT05278728
Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer
A Phase 1/2 study testing Nimotuzumab and Irinotecan in people with Colorectal Cancer, run by Biotech Pharmaceutical Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Nimotuzumab and Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2009to Dec 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Beijing, 100036
China People's Liberation Army (PLA)81 Hospital
Nanjing, Jiangsu
About this study
Official title: Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Nimotuzumab, Irinotecan
- Keywords
- nimotuzumab, colorectal cancer, chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
200,400,600 or 800mg weekly until progression or AEs
IrinotecanDrug
180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab and Irinotecan | Experimental | Nimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles Receives: Drug: Nimotuzumab; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of grade 3/4 toxicity
The rate of grade 3/4 toxicity, defined as the proportion or frequency of patients who experience toxicity reactions that are classified as grade 3 or grade 4 according to CTCAE v5.0.
Measured: 3 months
Secondary outcomes (4)
Maximum Tolerated Dose (MTD)
Rate of dose-limiting toxicities (DLTs) after infusion of nimotuzumab. The highest dose at which 0 or 1 DLT occurs in 6 DLT-evaluable subjects will be declared the maximum tolerated dose (MTD).
Measured: 3 months
The complete response rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), defined as the disappearance of all target lesions.
Measured: 3 months
The partial response rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Partial Response (PR), defined as at least a 30% decrease in the sum of the longest diameter of target lesions.
Measured: 3 months
The disease control rate
Disease control rate (DCR), including complete response (CR) and partial response (PR) and stable disease(SD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of the longest diameter of target lesions. SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (PD, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study startJul 2009
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Principal investigator, Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278728
- Sponsor's protocol ID
- BT-CRC-T
- Status last verified
- Feb 2025
- First submitted
- 18 Aug 2015
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras
- ClinicalTrials.gov ID
- NCT05278728
- Acronym / sponsor ID
- BT-CRC-T
- Conditions
- Colorectal Cancer
- Keywords
- nimotuzumab, colorectal cancer, chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- Jul 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab and Irinotecan | Experimental | Drug: Nimotuzumab, Drug: IrinotecanNimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nimotuzumab200,400,600 or 800mg weekly until progression or AEs | Drug | Nimotuzumab and Irinotecan |
| Irinotecan180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles | Drug | Nimotuzumab and Irinotecan |
Primary outcome
The rate of grade 3/4 toxicity
Time frame: 3 months
The rate of grade 3/4 toxicity, defined as the proportion or frequency of patients who experience toxicity reactions that are classified as grade 3 or grade 4 according to CTCAE v5.0.
4 secondary outcomes
Maximum Tolerated Dose (MTD)
Time frame: 3 months
The complete response rate
Time frame: 3 months
The partial response rate
Time frame: 3 months
The disease control rate
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Shen principal investigator
Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nimotuzumab and Irinotecan in people with Colorectal Cancer, run by Biotech Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of grade 3/4 toxicity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.