Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2026-01-20 @ 8:58 AM
Study NCT ID:
NCT01763450
Status:
UNKNOWN
Last Update Posted:
2013-01-29
First Post:
2012-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer
Sponsor:
Liaoning Cancer Hospital & Institute
Organization:
Study Overview
Official Title:
LIAONING CANCER HOSPITAL&INSTITUTE
Status:
UNKNOWN
Status Verified Date:
2012-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
PRIMARY OBJECTIVES：To assess the objective response rate(ORR)（8 weeks after chemotherapy）
SECONDARY OBJECTIVES：
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 chemotherapy）
SECONDARY OBJECTIVES：
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 chemotherapy）
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: