CompletedPhase 4

Avastin in Combination With Chemotherapy for RAS Mutant Unresectable Colorectal Liver-limited Metastases

China241 participantsStarted 2013-10

Plain-language summary

In this study, the investigators assessed the effect of avastin in combination with chemotherapy in the treatment of RAS mutant-type, unresectable colorectal liver-limited metastases

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 and ≤ 75 years;
✓. Primary tumour was histologically confirmed colorectal adenocarcinoma;
✓. Together with clinical or radiological evidence of first occurrence of non-resectable liver-only metastases
✓. With evidence of tumor RAS gene mutant status;
✓. With at least one measurable tumor.
✓. Performance status (ECOG) 0\~1
✓. A life expectancy of ≥ 3 months
✓. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)

Exclusion criteria

✕. Previous exposure to target therapy, chemotherapy, radiotherapy or intervention therapy for colorectal liver metastases.
✕. Known or suspected extrahepatic metastases.
✕. Patients with known hypersensitivity reactions to any of the components of the study treatments.
✕. Having previously participated in a study which included a possibility of being allocated to avastin therapy (whether or not the patient actually received avastin)
✕. Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or left ventricular ejection fraction (LVEF) below the institutional range of normal
✕. Acute or sub-acute intestinal occlusion
✕. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
✕. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

What they're measuring

the rate of patients converted to resection for liver metastases

Timeframe: 3 years

Trial details

NCT IDNCT01972490

SponsorXu jianmin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

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