Overview

Efficacy and Safety of Pyrotinib in HER2 Positive Gastrointestinal Tumors

Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
0
Participant gender:
All
Summary
Targeting human epidermal factor receptor 2 (HER2) therapy have shown the anti-tumor efficacy in patients with HER2-positive gastrointestinal tumors. Pyrotinib is an irreversible small-molecule receptor tyrosine kinase inhibitor targeting both epidermal growth factor receptor (EGFR) and HER2. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive gastrointestinal tumors.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Trastuzumab
Criteria
Inclusion Criteria:

1. Aged ≥18

2. ECOG performance status of 0 to 1.

3. Life expectancy of more than 12 weeks.

4. At least one measurable lesion exists.(RECIST 1.1) Histologically or cytologic
confirmed HER2 positive gastrointestinal tumors who failed prior therapies.

5. Required laboratory values including following parameters:

ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total
bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and
creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms

6. Signed informed consent.

Exclusion Criteria:

1. Subjects with third space fluid that can not be controled by drainage or other
methods.

2. Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal
absorption.

3. Less than 4 weeks from the last radiotherapy, chemotherapy, target therapy

4. Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry. Subjects
who can not interrupt the using of the drugs that may cause QT prolongation during
study.

5. Receiving any other antitumor therapy.

6. Known history of hypersensitivity to pyrotinib or any of it components. Ongoing
infection (determined by investigator).

7. History of immunodeficiency, including HIV-positive, suffering from other acquired,
congenital immunodeficiency disease, or history of organ transplantation.

8. Subjects had any heart disease, including: (1) angina; (2) requiring medication or
clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5)
Any heart diseases judged by investigator as unsuitable to participate in the trial.

9. Female patients who are pregnancy, lactation or women who are of childbearing
potential tested positive in baseline pregnancy test.

10. Known history of neurological or psychiatric disease, including epilepsy or dementia.