Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05278728
Other study ID # BT-CRC-T
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date July 2009
Est. completion date December 2013

Study information

Verified date August 2015
Source Biotech Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Peking University, School of Oncology, Beijing Cancer Hospital & Institute Beijing
China China People's Liberation Army (PLA)81 Hospital Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of grade 3/4 toxicity 3 months
Secondary The maximum tolerated 3 months
Secondary The complete response rate 3 months
Secondary The partial rate 3 months
Secondary The disease control rate 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A