Cetuximab Plus FOLFOXIRI vs Cetuximab Plus FOLFOX For CRCLM (NCT03493048) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Cetuximab Plus FOLFOXIRI vs Cetuximab Plus FOLFOX For CRCLM
China146 participantsStarted 2018-04-15
Plain-language summary
The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis of RAS wildtype. The patients will be treated in two therapy groups:
Experimental arm A: Chemotherapy with FOLFOXIRI + Cetuximab Standard arm B: Chemotherapy with FOLFOX + Cetuximab
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Liver metastasis confirmed by imaging or pathology.
✓. The multidisciplinary team (MDT) determines that the liver metastases are unresectable, which is specifically defined as ①metastatic lesions ≥ 5; ② ineligible for R0 resection; ③ expected insufficient residual liver volume after resection; ④ unable to preserve all three hepatic veins after resection, unable to ensure that the blood flow and bile ducts of the residual liver into and out of the liver could be preserved, and unable to preserve the adjacent two liver segments. Patients who meet any of the above criteria can be determined as having initially unresectable liver metastases.
✓. Patients with wild-type RAS.
✓. No prior treatment for liver metastases, including chemotherapy, surgery, radiotherapy, transcatheter arterial chemoembolization (TACE), and targeted therapy.
✓. Absence of extrahepatic metastasis confirmed by CT, MRI or PET/CT (if necessary) (enrollment can be considered if there is a lung or lymph node lesion less than 10 mm, which is difficult to determine metastases).
✓. Normal hematologic function (platelets \> 90 × 109/L; leukocytes \> 3 × 109/L; neutrophils \> 1.5 × 109/L).
Exclusion criteria
✕. Presence of any extrahepatic metastasis and/or primary tumor that cannot be resected with radical surgery.
✕. Have bleeding tendency or coagulation disorder.
✕. Have hypertensive risk or hypertensive encephalopathy.
✕. Serious uncontrolled systemic complications such as infection or diabetes.
✕. Clinically significant cardiovascular disease such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite appropriate medical treatment. Unstable angina, congestive heart failure (NYHA class 2-4), cardiac arrhythmia requiring medication.
✕. History or physical evidence of central nervous system disease (e.g., primary brain tumor, epilepsy uncontrolled by standard of care, any history of brain metastases or stroke).
✕. History of other malignancies (except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix after radical surgery) within the past 5 years.