CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastati… (NCT03206151) | Clinical Trial Compass
CompletedPhase 3
CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer
China520 participantsStarted 2017-12-12
Plain-language 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 cancer（first-line treatment）may 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 FOLFIRI（5-Fluorouracil /Folinic acid plus Irinotecan）for RAS/BRAF wild-type, metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone.
Who can participate
Age range18 Years – 75 Years
SexALL
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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)
Exclusion criteria
✕. Radiotherapy or surgery（excluding prior diagnostic biopsy）in the 30 days before trial treatment
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.
✕. Hepatic, marrow, liver and renal function as follows:
✕. 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