A Study of Bevacizumab Plus 5-Flurouracil (5-FU) Based Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Previously Untreated Unresectable Liver-Only Metastases From Colorectal Cancer

A Multi-Center, Single-Arm, Pilot Study of 5-FU Based Doublet Chemotherapy Plus Bevacizumab as Neoadjuvant Therapy for Patients With Previously Untreated Unresectable Liver-Only Metastases From Colorectal Cancer

This open-label, single arm, multicenter study evaluated the resection rate in participants with colorectal cancer and previously untreated unresectable liver-only metastases after adding bevacizumab to 5-FU based doublet chemotherapy in the neoadjuvant setting. Participants receive standard 5-FU based chemotherapy plus Avastin bevacizumab 5 milligrams per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and postoperatively, unless they experienced progressive disease or unacceptable toxicity.

Inclusion Criteria:

• Adult Chinese participants, 18-75 years of age
• Histologically confirmed adenocarcinoma in colon or rectum with primary lesion surgically removed
• Previously untreated unresectable liver-only metastases
• Liver lesions determined to be unresectable by multidisciplinary team (MDT, consisting of experienced hepatic surgeons, medical oncologist and radiologist).
• No previous treatment against liver metastases, including chemotherapy, surgery, radiotherapy, Transarterial chemoembolisation therapy (TACE) and target therapy
• Adequate hematological, renal and hepatic function
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Life expectancy greater than (>) 3 months

Exclusion Criteria:

• The relapse has occurred within 6 months of completion of the adjuvant treatment
• Expected impossible to achieve complete resection (R0 resection) and/or gain 30% residual liver volume even with responsive neoadjuvant therapy
• Participant cannot tolerate the surgery
• Other malignancies in the past 5 years, except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
• Any extrahepatic metastases and/or recurrence of the primary tumor
• Any residual toxicity from previous chemotherapy (except alopecia) of National Cancer Institute Common Toxicity Criteria (NCI CTC) v.4.0 grade 2
• Hypertension crisis or encephalopathy
• Pregnant or lactating women
• Clinically significant cardiovascular disease
• Evidence of bleeding diathesis or coagulopathy
• Current or recent (within 10 days of study drug initiation) use of full dose of aspirin, clopidrogel or warfarin
• History or evidence of Central Nervous System (CNS) disease (for example, primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)