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
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: 5-FU based doublet chemotherapy; bevacizumab
Intervention description: Standard 5-FU based doublet chemotherapy. Protocol did not specify any particular chemotherapy regimen. The choice of 5-FU based doublet chemotherapy was as per standard of practice and the dosage of 5-FU based doublet chemotherapy was as per product labels.; 5 mg/kg every 2 weeks, up to 12 cycles pre- and postoperatively
Intervention MeSH terms: Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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)