A Clinical Study of Pyrotinib in Patients of Advanced Colorectal Cancer With Her2 Variation

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Recruiting
participants needed

40
sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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Updated on 19 February 2024

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blood transfusion

platelet count

absolute neutrophil count

metastasis

neutrophil count

liver metastasis

ejection fraction

immunohistochemistry

trastuzumab

erbb2

her-2

pyrotinib

12 lead electrocardiogram

colorectal cancer

HER2

Summary

To Observe the Efficacy and Safety of Pyrotinib Maleate in Patients With Advanced HER2 Variation Colorectal Cancer

Description

Investigators identified HER2 amplification as a potential onco-driver and marker of de novo resistance to anti-EGFR therapy in mCRC patients for which other known genetic alterations conferring resistance to anti EGFR antibodies were excluded.

This study is an open-label Phase II, 2-sequential cohorts trial, assessing the response rate (ORR) of Pyrotinib (Cohort 1) or Trastuzumab combined Pyrotinib (Cohort 2), in metastatic colorectal patients harboring an amplified HER2 tumors .

HER2 positivity is centrally established by immunohistochemistry (IHC) and Silver In Situ Hybridization (SISH). To be HER2 eligible the original tumor, or the biopsied metastasis (whichever is last available), must be IHC 3+ or 2+ in more than 50% of cells, confirmed by SISH or FISH with a HER2:CEP17 ratio 2.0. For IHC a positive staining (3+) is defined as an intense membrane staining which can be circumferential, basolateral, or lateral of the tumor cells.

The study was a investigator-initiated multicenter clinical study to enroll 40 colorectal cancer patients with Her-2 Variation who were treated with either Pyrotinib alone or with Trastuzumab, 20 Patients in each group.The inclusion time was 1 year, and the follow-up time was 1 year. The Efficacy and Safety of Pyrotinib in Combination With or Without Trastuzumab in the treatment of Advanced Colorectal Cancer were evaluated with objective efficacy and safety as the main indicators.

Details

Condition	Colorectal Cancer, Colorectal Cancer, Rectal disorder
Age	18years - 75years
Treatment	Pyrotinib, Pyrotinib in combination with trastuzumab
Clinical Study Identifier	NCT04380012
Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	18 years old age 75 years old, male or female
	\. The ECOG PS score is 0 to 2 points
	\. Patients with recurrent/metastatic advanced colorectal cancer diagnosed by histology or cytology
	\. The subject may be a HER-2 variant of colorectal cancer who is treated with first, second or second line (a patient who refuses to receive chemotherapy at the first line, or the investigator determines that the patient cannot tolerate chemotherapy and can be enrolled)
	\. According to the RECIST 1.1 standard, at least one measurable target lesion is present
	\. Clinically recognized methods (including PCR, FISH, immunohistochemistry, and NGS) detect HER2 mutations (including amplification, mutation, and overexpression), and recognize hospital pathology and qualified genes. The data obtained by the second generation of sequencing (NGS) by the testing organization
	The functional level of the main organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes, platelet-up 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 value (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2 ULNPatients with liver metastases were 5 ULN
	cardiac color Doppler ultrasound: left ventricular ejection fraction (LVEF) 55%
	12-lead ECG: The QT interval (QTcF) corrected by the Fridericia method is < 470 msec
	\. Sign the informed consent and agree to collect the clinical efficacy and information of the patient
Exclusion Criteria
	\. 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
	\. Have a history of substance abuse and cannot be cured or have mental disorders
	\. Pregnant or nursing women;Patients with fertility who are unwilling or unable to use effective contraception
	\. The patient has severe concomitant disease or the researcher considers it inappropriate to participate in this study
	\. The previous clinical treatment with Pyrotinib was not included in this study

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A Clinical Study of Pyrotinib in Patients of Advanced Colorectal Cancer With Her2 Variation