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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    512
  • sponsor
    Taizhou Mabtech Pharmaceutical Co.,Ltd
Updated on 25 January 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 on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males or females, Aged 18 years and 75 years
Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
First occurrence of metastatic disease(not curatively resected)
RAS/BRAF wild-type status in tumor tissue
At least one measurable lesion by computer tomography(CT) or magnetic resonance imaging (MRI)according to RECIST1.1 criteria (not in an irradiated area)
Eastern Cooperative Oncology Group(ECOG)performance status of 0 or 1 at trial entry
Life expectancy of at least 3 months
Medically accepted effective contraception if procreative potential exists(applicable for both male and female subjects until at least 90 days after the last dose of trial treatment)
Recovery from relevant toxicity due to previous treatment before trial entry
Signed the informed consent form voluntarily

Exclusion Criteria

Radiotherapy or surgeryexcluding prior diagnostic biopsyin the 30 days before trial treatment
Hepatic, marrow, liver and renal function as follows
Marrow: white blood cell count <3.0 109/L with neutrophils<1.5 109/L, platelet
count<100109/L and hemoglobin<90 g/L; Liver function: Total bilirubin >1.5
upper limit of reference range; Aspartate transaminase (AST) and alanine
transaminase (ALT) > 2.5 upper limit of reference range , or> 5 upper
reference range in subjects with liver metastasis; Renal function: Serum
creatinine >1.5 upper limit of reference range, or creatinine clearance<50
mL/min
\. Previous chemotherapy for CRC adjuvant treatment if terminated <12 months
before diagnosis of recurrence or metastatic disease
\. Previous treatment with anti-EGFR monoclonal antibody, epidermal growth
factor receptor tyrosine kinase inhibitor, or other EGFR targeted
inhibitors(such as cetuximab, Nimotuzumab, or panitumumab)
\. Known hypersensitivity or allergic reactions against any of the components
of the trial treatments
\. History of organ allograft, autologous stem cell transplantation, or
allogeneic stem cell transplantation
\. Other non-permitted concomitant anti-cancer therapies
\. Known brain metastasis and/or leptomeningeal disease
\. Previous malignancy other than CRC in the last 5 years except basal cell
cancer of the skin or preinvasive cancer of the cervix
\. Participation in another clinical trial within the past 30 days
\. Concurrent chronic systemic immune therapy or hormone therapy except
physiologic replacement
\. Any unstable systemic disease, such as active infection, uncontrolled
hypertension, unstable angina pectoris, angina in the last 3 months, cardiac
failure of New York Heart Association classes II, history of myocardial
infarction, serious cardiac arrhythmias that require drug treatment, liver
kidney or metabolic disease in the last 6 months
\. Acute or sub-acute intestinal occlusion or history of inflammatory bowel
disease
\. severe bone marrow function failure
\. Any disease, metabolic disorders, or physical/laboratory examination
suspected, or patients with high risk of complications
\. Known and declared history of human immunodeficiency virus(HIV)infection
\. HBV-DNA >1.0 103copy
\. Pregnancy or breastfeeding
\. Alcohol or drug abuse
\. Legal incapacity or limited legal capacity
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