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Phase 2
18 Years
80 Years
Open (Enrolling)
Liver Metastases, Colorectal Cancer

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Trial Information


PRIMARY OBJECTIVES:To assess the objective response rate(ORR)(8 weeks after chemotherapy)


1. To assess the R0 resection rate of liver metastases(8 weeks after chemotherapy、every
three months follow-up 1 time in R0 postoperative 1-2 years、Every six months follow-up
1 time in R0 postoperative 2-5 years)

2. To assess the incidence of adverse events of level 3-4 (Bleeding、Gastrointestinal
Perforation、Anastomotic Fistula、Hypertension、Wound Healing Delay)(8 weeks after

Inclusion Criteria:

1. Written inform consent form

2. histologically or cytologically confirmed Colorectal Adenocarcinoma

3. Age≥18 and ≤80 years old

4. Primary colorectal cancer and liver metastases,Liver lesions determined to be
unresectable by multidisciplinary team (MDT) (primary lesions surgically removed)

5. Simultaneity or heterochrony metastases

6. Colorectal cancer lesions from anal edge at least 8 cm

7. Within 6 months did not receive any chemotherapy, including targeted therapy

8. One or more measurable lesions, conventional Computed Tomography(CT) scanning
measurement diameter at least 20 mm [Response Evaluation Criteria In Solid
Tumors(RECIST) standard]

9. Eastern Collaborative Oncology Group(ECOG) 0 or 1

10. Expected lifetime at least for 12 weeks

11. Screening within 7 days, the ability of bone marrow, liver and kidney function
reserve enough;Absolute neutrophil count(ANC)≥1.5x109/L; hemoglobin≥9.0g/dl; platelet
count≥80 x109/L; Total Bilirubin(TBil)≤1.5 x upper level of normal range(ULN);
Alanine Aminotransferase(ALT) and Aspartate Aminotransferase(AST)≤2.5 x ULN(Patients
with hepatic metastasis≤5x ULN); alkaline phosphatase≤4 x ULN; serum creatinine≤1.5 x

12. Women of reproductive age should take effective contraceptive measures;

Exclusion Criteria:

1. Arrhythmia requiring medication(except β- receptor blocking pharmacon and
digoxigenin),symptomatic coronary artery disease and myocardial ischemia [myocardial
infarction (≤6months before enrollment)],congestive heart failure [≥New York Heart

2. History of HIV infection,Chronic hepatitis B or hepatitis C of active phase(high copy
virus DNA);

3. Other activated serious infection [>National Cancer Institute-Common Toxicity
Criteria(NCI-CTC) 3.0];

4. Any extrahepatic metastases;

5. Seizures requiring medication(such as steroids or antiepileptic therapy);

6. Other malignancies in the past 5 years (except curatively treated basal cell
carcinoma of the skin and/or in situ carcinoma of the cervix);

7. Chronic inflammatory bowel disease, intestinal obstruction;

8. Drug abuse and medicine, psychology or social conditions may interfere with patients
to participate in research or the results of the evaluation have influence;

9. Known or suspected allergy to any investigational drug in this study;

10. Any unstable condition or is likely to endanger the patient safety and compliance

11. Pregnant or lactating women not using or refusing to use effective non hormonal means
of contraception;

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the objective response rate(ORR)

Outcome Time Frame:

8 weeks after chemotherapy

Safety Issue:


Principal Investigator

Chun Song, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:



China: Food and Drug Administration

Study ID:

Avastin Study



Start Date:

September 2012

Completion Date:

September 2014

Related Keywords:

  • Liver Metastases
  • Colorectal Cancer
  • Bevacizumab
  • conversion therapy
  • liver metastases
  • colorectal cancer
  • objective response rate
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms