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A multi-center, non-random, open study ,to observe efficacy and safety of bevacizumab plus Oxaliplatin based multidrug chemotherapy as conversion therapy for patients with previously untreated unresectable liver metastases from colorectal cancer.
PRIMARY OBJECTIVES:To assess the objective response rate(ORR)(8 weeks after chemotherapy)
SECONDARY OBJECTIVES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab plus chemotherapy | Experimental |
Oxaliplatin: 85mg/m2,iv for 2 hours ,d1; Levomisole(LV): 400mg/m2,iv for 2 hours,d1; 5-Fluorouracil(5-FU) :400mg/m2 iv,d1,then 1200mg/m2/d ×2d continuous intravenous infusion(volume dose:2400mg/m2,iv for 46-48 hours ) each 14 day cycle; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab plus chemotherapy | Drug |
Oxaliplatin: 85mg/m2,iv for 2 hours ,d1; Levomisole(LV): 400mg/m2,iv for 2 hours,d1; 5-Fluorouracil(5-FU) :400mg/m2 iv,d1,then 1200mg/m2/d ×2d continuous intravenous infusion(volume dose:2400mg/m2,iv for 46-48 hours ) each 14 day cycle; |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the objective response rate(ORR) | 8 weeks after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the incidence of adverse events of level 3-4 (Bleeding、Gastrointestinal Perforation、Anastomotic Fistula、Hypertension、Wound Healing Delay) | 8 weeks after chemotherapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun Song, Ph.D | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hosptial of Harbin Medical University | Harbin | Heilongjiang | 150086 | China | ||
| Liaoning Cancer Hospital&Institute |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Shenyang |
| Liaoning |
| China |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |