CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type Metastatic Colorectal Cancer

  • End date
    Jun 30, 2022
  • participants needed
  • sponsor
    Taizhou Mabtech Pharmaceutical Co.,Ltd
Updated on 24 November 2021
measurable disease
folfiri regimen
adenocarcinoma of colon


Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as CMAB009, can block tumor growth in different ways. Giving combination chemotherapy together with CMAB009 as first treatment after diagnosis of a metastatic colorectal cancerfirst-line treatmentmay improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with CMAB009 is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of CMAB009 in combination with a standard and effective chemotherapy FOLFIRI5-Fluorouracil /Folinic acid plus Irinotecanfor RAS/BRAF wild-type, metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone.


Patients will be randomly assign in one of the two groups to either receive the combination chemotherapy alone or with CMAB009 and will then be treated until progression of the disease or unacceptable toxicity occurred. Regular efficacy assessmentsevery 8 weeksbased on imaging will be performed throughout the study together with regular safety assessments.

After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.

Condition Metastatic Colorectal Cancer
Treatment Irinotecan, 5-fluorouracil, Folinic Acid, CMAB009
Clinical Study IdentifierNCT03206151
SponsorTaizhou Mabtech Pharmaceutical Co.,Ltd
Last Modified on24 November 2021

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