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
Inclusion Criteria:
- Adult Chinese patients, 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).
Guidelines used to determine unresectability includes:
- R0 treatment infeasible with resection
- cannot spare two adjacent liver segments
- retention of liver volume <30%
- vascular flow and biliary drainage cannot be preserved
- No previous treatment against liver metastases, including chemotherapy, surgery,
radiotherapy, TACE and target therapy
- Adequate hematological, renal and hepatic function
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy > 3 months
Exclusion Criteria:
- The relapse has occurred within 6 months of completion of the adjuvant treatment
- Expected impossible to achieve R0 resection and/or gain 30% residual liver volume
even with responsive neoadjuvant therapy
- Patient 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 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 CNS disease (e-g- primary brain tumor, seizures not controlled
with standard medical therapy, any brain metastases, or history of stroke)