Back to resultsPyrotinib in Combination With Trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pyrotinib
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring HER2, Pyrotinib, Trastuzumab, Metastatic Colorectal Cancar
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
HER2-positive Metastatic Colorectal Cancar
Arm Description
Outcomes
Primary Outcome Measures
Objective Response Rate(ORR)
Evaluation of tumor burden based on RECIST criteria.
Secondary Outcome Measures
Full Information
NCT ID
NCT03843749
First Posted
February 14, 2019
Last Updated
February 15, 2019
Sponsor
Shanghai Changzheng Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03843749
Brief Title
Pyrotinib in Combination With Trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
Official Title
Pyrotinib in Combination With Trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
July 1, 2022 (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 Pyrotinib in combination with trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
HER2, Pyrotinib, Trastuzumab, Metastatic Colorectal Cancar
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
HER2-positive Metastatic Colorectal Cancar
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Other Intervention Name(s)
Trastuzumab
Intervention Description
Pyrotinib in Combination With Trastuzumab
Primary Outcome Measure Information:
Title
Objective Response Rate(ORR)
Description
Evaluation of tumor burden based on RECIST criteria.
Time Frame
up to 36 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:
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
Wei-ping Dai
Phone
+8618801790929
Email
18801790929@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
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
Yuan-sheng Zang, Prof.
Phone
+8613816584620
Email
doctorzangys@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Pyrotinib in Combination With Trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
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