Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy (BEVIAC)

This is an interventional treatment trial for Colorectal Neoplasms Read More

Inclusion Criteria:

• Liver metastases of colon cancer or rectal predominant (histological evidence obtained on the primary tumor or liver metastases)

  • Isolated (no extra-hepatic metastasis, primary tumor resected)
  • No access to curative hepatectomy (R0 resection foreseeable or not leaving less than 30% residual non-tumor liver normally vascularized), or requiring complex hepatectomy, very large (5 or more segments) and / or risked (class II CPP)
  • which at least one measurable by RECIST (>2 cm, or >1 cm if Computed tomography (CT) spiraled)
  • Or extra-hepatic disease of small size potentially accessible to a resection (one or two lung metastases, lymphadenopathy localized accessible to curative resection)
  • colon or rectal primary tumor : resected or asymptomatic
• Progression after first line chemotherapy to treat the metastatic disease, all types of treatment allowed except intra-arterial Bevacizumab
• Age >18 years <75 years
• Performance status WHO 0 or 1
• Life expectancy >3 months
• Bilirubin <1.5 times the upper limit of normal (N), ASAT and ALAT <5N, creatinine <1.5 N neutrophils >1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin >9g/dL. Patients may be included even if they were transfused
• CT (or MRI) reference for the measurement of metastases performed within 28 days before the first treatment cycle
• Information of the patient or legal representative signing the informed consent
• Affiliated to a social security system

Exclusion Criteria:

• Symptomatic colon or rectal primary tumor (sub-occlusion, significant hemorrhage, major rectal syndrome)
• Extra-hepatic metastases other than small size disease potentially accessible after resection
• Grade 3-4 allergy to one of the treatment compounds
• Two lines of prior chemotherapy. One line is allowed for metastatic disease but must have been started more than 6 months after completion of adjuvant treatment.
• Participation during or within 30 days before study to another therapeutic trial with an experimental molecule
• Concomitant cancer systemic treatment using immunotherapy, chemotherapy or hormone
• Symptomatic CHD or myocardial infarction within 6 months prior entry into the study, cardiac arrhythmia uncontrolled despite treatment
• Uncontrolled hypertension (blood pressure >150/100 mm Hg despite hypertensive treatment)
• Heart Failure >Grade II of the New York Heart Association (NYHA) (class II-III-IV)severe renal failure
• History and / or presence of bleeding disorders and/or thrombotic <6 months
• Uncontrolled Serious illness, uncontrolled active infection or other serious underlying condition which may prevent the patient to receive treatment
• Pregnancy (or positive pregnancy test at baseline), lactation or no contraception effective for men or women of childbearing age
• Occlusion or sub-bowel obstruction or history of inflammatory bowel disease
• Other cancer within 5 years prior to entry into the trial or concomitant (except in situ cancer of the cervix or skin basal-cell carcinoma properly treated)
• Legal inability (persons deprived of liberty or under guardianship)
• Inability to sign the consent or submit to medical test for geographical, social or psychological reasons.