A Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer
NCT ID: NCT04227041
Last Updated: 2020-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2020-01-10
2023-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HER2 positive metastatic colorectal cancer
Pyrotinib in combination with capecitabine
Pyrotinib in combination with capecitabine
Interventions
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Pyrotinib in combination with capecitabine
Pyrotinib in combination with capecitabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with HER2 positive；
3. Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1)；
4. Life expectancy is at least 6 months
5. ECOG score 0-1；
6. The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes or platelets)：
Exclusion Criteria
2. Patients who have previously been treated with anti-Her2-targeted drugs；
3. Patients with surgical opportunity or potential for surgical treatment；
4. Patients with a high risk of bleeding or perforation due to a tumor that has apparently invaded adjacent organs (including large vessels) of the colorectal lesion or who have developed fistulas；
5. Patients with any severe and/or uncontrolled disease;
6. Patients with any or present brain metastases；
7. Women who were pregnant or breast-feeding.
18 Years
75 Years
ALL
No
Sponsors
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The Affiliated Hospital of Qingdao University
OTHER
Qingdao Zhixin Health Technology Co., Ltd.
OTHER
Responsible Party
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Nailong Yang
Principal Investigator
Locations
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Qingdao University Hospital
Qingdao, Shandong, China
Countries
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Central Contacts
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Other Identifiers
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QingdaoZHT
Identifier Type: -
Identifier Source: org_study_id
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