The aim of this study is to explore whether cetuximab in combination with mFOLFOX6 as
treatment could improve the resection rate in patients with KRAS wild-type, unresectable
liver metastases of mCRC.
Drug: Cetuximab; mFOLFOX6
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Full eligibility criteria for NCT01322178
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Male or female 18-75 years of age
Performance status (ECOG) 0~1
Unresectable, histologically confirmed, synchronous or metachronous liver metastasis of colorectal cancer. Unresectable liver metastases is defined as:
patients with five and more liver metastases and/or
Liver metastases that are technically unresectable immediately, and expected remaining functional liver tissue ≥ 30% after resection. (Patients should be evaluated by a multidisciplinary team of three local surgeons and one local radiologist, including surgical consultation for potentially resectable patients on the basis of remaining liver volume, infiltration of all liver veins, infiltration of both liver arteries, both portal branches or both bile ducts.)
Tumor tissue (primary or metastasis) genotypologically classified as KRAS wild-type in codon 12 and codon 13 of the KRAS gene exon 2
No prior chemotherapy (except adjuvant chemotherapy with an interval of ≥ 6 months)
Presence of at least one index lesion of hepatic metastasis measurable by CT scan or MRI, not in an irradiated area
Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL
Bilirubin level ≤ 1.0 x ULN
AST and ALT < 1.5 x ULN
Serum creatinine ≤ 1.0 x ULN
Life expectancy of ≥ 3 months
Male or female of child-bearing period should have effective contraception
Signed written informed consent
Any investigational agent(s) within 4 weeks prior to entry
Previous exposure to EGFR-targeting therapy
Any evidence of extrahepatic metastases and/or primary tumor recurrence
Total volumes of liver lesions > 70%
Clinically relevant peripheral neuropathy
Acute or sub-acute intestinal obstruction or history of inflammatory bowel disease
Breast-feeding or pregnant women, no effective contraception if risk of conception exists (for male and female patients up to 4 months after end of chemotherapy)
Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
Known drug abuse/ alcohol abuse
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Severe organ failures or diseases, including: clinically relevant coronary disease, cardiovascular disorder or myocardial infarction within 12 months before study entry, severe psychiatric illness, severe infection and DIC
All locations for NCT01322178
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China
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Tris trial is registered with FDA with number: NCT01322178. The sponsor of the trial is Fudan University and it is looking for 90 volunteers for the current phase.
Official trial title: Open-label, Uncontrolled, Multi-center, Phase II Study of Cetuximab in Combination With mFOLFOX-6 as First-line Treatment in Patients With KRAS Wild-type, Unresectable LIver Metastases of colorEctal Cancer
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