Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer

NCT ID: NCT05278728

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-12-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nimotuzumab and Irinotecan

Nimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

200,400,600 or 800mg weekly until progression or AEs

Irinotecan

Intervention Type: DRUG

180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles

Interventions

Nimotuzumab

200,400,600 or 800mg weekly until progression or AEs

Intervention Type: DRUG

Irinotecan

180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Shen

Role: PRINCIPAL_INVESTIGATOR

Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Locations

China People's Liberation Army (PLA)81 Hospital

Nanjing, Jiangsu, China

Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Beijing, , China

Countries

China

Other Identifiers

BT-CRC-T

Identifier Type: -

Identifier Source: org_study_id