Status:
UNKNOWN
A Clinical Study of Pyrotinib in Patients With HER2-positive Advanced Colorectal Cancer
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Zhejiang Cancer Hospital
Zhejiang Provincial People's Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To Observe the Efficacy and Safety of Pyrotinib Maleate in Patients With HER2-positive Advanced Colorectal Cancer
Detailed Description
This study is an investigator-initiated, open-label, two-cohort phase II trial, assessing the objective response rate (ORR) of pyrotinib monotherapy (Cohort 1) or in combination with trastuzumab (Coho...
Eligibility Criteria
Inclusion
- 1\. Aged 18-75 years, male or female;
- 2\. ECOG performance status 0-2;
- 3\. Recurrent/metastatic advanced colorectal cancer diagnosed by histology or cytology;
- 4\. Patients who progressed on or were intolerable to standard therapy, or those who refused chemotherapy;
- 5\. At least one measurable lesion according to RECIST v1.1;
- 6\. HER2 positivity (including amplification, mutation, and overexpression) detected by clinically recognized methods (including PCR, FISH, immunohistochemistry, and NGS), and the data obtained by NGS at the pathology department of hospital or qualified gene testing organization could be accepted;
- 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 platelet-raising drugs):
- Blood routine: neutrophils (ANC) ≥ 1.5 × 10\^9 / L; platelet count (PLT) ≥ 90 × 10\^9 / L; hemoglobin (Hb) ≥ 90 g / L;
- Blood biochemistry: total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × ULN（Patients with liver metastases were ≤5 × ULN）;
- Cardiac color doppler ultrasound: left ventricular ejection fraction (LVEF) ≥ 55%;
- 12-lead electrocardiogram: The QT interval corrected by the Fridericia method (QTcF) \< 470 msec;
- 8\. Sign the informed consent and agree to collect the clinical efficacy and information of the patient.
Exclusion
- 1\. The presence of third interstitial effusion (such as a large amount of pleural fluid and ascites) that cannot be controlled by drainage or other methods makes it impossible to evaluate the clinical treatment effect;
- 2\. History of substance abuse and cannot be cured or with mental disorders;
- 3\. Pregnant or lactating women; patients with fertility who are unwilling or unable to use effective contraception;
- 4\. Severe concomitant disease, or unsuitable to participate in this study decided by the investigator.
- 5\. Prior use of pyrotinib.
Key Trial Info
Start Date :
December 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 17 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04380012
Start Date
December 17 2019
End Date
June 17 2022
Last Update
July 15 2021
Active Locations (1)
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1
The Second Affiliated hospital of Zhejiang University School of Medical
Hangzhou, Zhejiang, China, 310009