Back to resultsALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ALK Inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring ALK mutation, ALK inhibitor, Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
Patients should be histologically diagnosed with metastatic colorectal cancer or postoperative recurrence; Patients with ALK mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;
Exclusion Criteria:
Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.
Sites / Locations
- Shanghai Changzheng HospitalRecruiting
- Shanghai Changzheng HospitalRecruiting
- Shanghai Changzheng HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALK mutation
Arm Description
Outcomes
Primary Outcome Measures
Objective Respone Rate(ORR)
Evaluation of tumor burden based on RECIST criteria every 2 month.
Secondary Outcome Measures
Full Information
NCT ID
NCT03792568
First Posted
January 2, 2019
Last Updated
February 14, 2019
Sponsor
Shanghai Changzheng Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03792568
Brief Title
ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.
Official Title
ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital
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
This clinical trial aims to evaluate the efficacy, safety of ALK inhibitor in Metastatic Colorectal Cancer Patients with ALK mutation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
ALK mutation, ALK inhibitor, Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALK mutation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
ALK Inhibitor
Intervention Description
Any ALK inhibitor like crizotinib, alectinib and so on.
Primary Outcome Measure Information:
Title
Objective Respone Rate(ORR)
Description
Evaluation of tumor burden based on RECIST criteria every 2 month.
Time Frame
up to 36months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients should be histologically diagnosed with metastatic colorectal cancer or postoperative recurrence; Patients with ALK mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;
Exclusion Criteria:
Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.
Facility Information:
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan-sheng Zang, Prof.
Phone
+8613816584620
Email
doctorzangys@163.com
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhan Wang, Prof.
Phone
+8613916229609
Email
profoundamir@139.com
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-ping Dai
Phone
+8618801790929
Email
18801790929@139.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.
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