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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    512
  • sponsor
    Taizhou Mabtech Pharmaceutical Co.,Ltd
Updated on 24 November 2021
measurable disease
fluorouracil
BRAF
metastasis
leucovorin
irinotecan
adenocarcinoma
folfiri regimen
adenocarcinoma of colon

Summary

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.

Description

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.

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

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note