Pyrotinib in Combination With Trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
1 other identifier
interventional
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable colorectal-cancer
Started Jul 2019
Typical duration for not_applicable colorectal-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
February 18, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedFebruary 18, 2019
February 1, 2019
Same day
February 14, 2019
February 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate(ORR)
Evaluation of tumor burden based on RECIST criteria.
up to 36 months
Study Arms (1)
HER2-positive Metastatic Colorectal Cancar
EXPERIMENTALInterventions
Pyrotinib in Combination With Trastuzumab
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200433, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200433, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200433, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pyrotinib in Combination With Trastuzumab in Treatment-refractory, HER2-positive Metastatic Colorectal Cancar.
Study Record Dates
First Submitted
February 14, 2019
First Posted
February 18, 2019
Study Start
July 1, 2019
Primary Completion
July 1, 2019
Study Completion
July 1, 2022
Last Updated
February 18, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will share