Back to resultsStudy Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM
Primary Purpose
Colorectal Adenocarcinoma Metastatic to the Liver
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HAI
chemotherapy ± target therapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Adenocarcinoma Metastatic to the Liver focused on measuring colorectal cancer, liver metastasis, hepatic arterial infusion, chemotherapy, target therapy, conversional resection rates
Eligibility Criteria
Inclusion Criteria:
- All patients must meet the following criteria:
- Patients must have histologically confirmed incurable CRLM and no clinical or radiographic evidence of extrahepatic disease
- Patients is medically eligible to receive HAI, as determined by the MDT (multidisciplinary team)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Age > 18 years
- Subject life expectancy > 3 months
- Platelets > 100×103/mm3
- Total bilirubin <1.5mg/dl
- Creatinine level < 2.0 mg/dl
- All patients must sign an informed consent form
Exclusion Criteria:
- The CRLM is amenable to curative surgical therapy
- Prior radiation, TACE or HAI to the liver
- Uncorrectable coagulopathy
- Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival
- Current or planned treatment with any experimental chemotherapy or target drugs
Sites / Locations
- Zhongshan hosptial, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
HAI plus chemotherapy ± target therapy
chemotherapy ± target therapy
Outcomes
Primary Outcome Measures
conversional resection rates
Secondary Outcome Measures
overall response rates
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03125161
Brief Title
Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM
Official Title
A Prospective, Randomized, One-center Study Comparing Hepatic Arterial Infusion Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Colorectal Cancer Liver Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2017 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To date no prospective trials have been completed that demonstrated whether HAI is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine conversional resection rates and survival for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenocarcinoma Metastatic to the Liver
Keywords
colorectal cancer, liver metastasis, hepatic arterial infusion, chemotherapy, target therapy, conversional resection rates
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
HAI plus chemotherapy ± target therapy
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
chemotherapy ± target therapy
Intervention Type
Drug
Intervention Name(s)
HAI
Intervention Description
HAI
Intervention Type
Drug
Intervention Name(s)
chemotherapy ± target therapy
Intervention Description
chemotherapy ± target therapy
Primary Outcome Measure Information:
Title
conversional resection rates
Time Frame
2-4 months
Secondary Outcome Measure Information:
Title
overall response rates
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients must meet the following criteria:
Patients must have histologically confirmed incurable CRLM and no clinical or radiographic evidence of extrahepatic disease
Patients is medically eligible to receive HAI, as determined by the MDT (multidisciplinary team)
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Age > 18 years
Subject life expectancy > 3 months
Platelets > 100×103/mm3
Total bilirubin <1.5mg/dl
Creatinine level < 2.0 mg/dl
All patients must sign an informed consent form
Exclusion Criteria:
The CRLM is amenable to curative surgical therapy
Prior radiation, TACE or HAI to the liver
Uncorrectable coagulopathy
Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival
Current or planned treatment with any experimental chemotherapy or target drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Xu, PhD
Phone
+86-13501984869
Email
xujmin@aiiyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu, PhD
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan hosptial, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu, PhD
Phone
+86-13501984869
Email
xujmin@aiiyun.com
12. IPD Sharing Statement
Learn more about this trial
Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM
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