Clinical trial · Interventional
Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer
Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab and Irinotecan
- 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
- interventionNames
- Drug: Nimotuzumab
- Drug: Irinotecan
Primary outcomes (1)
- measure
- The rate of grade 3/4 toxicity
- timeFrame
- 3 months
- description
- 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.
Secondary outcomes (4)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available