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A single arm, open-label Phase II clinical study.The subjects were patients with lung, gastric and colorectal cancers.
Object: 1.The main purpose: T To observe and evaluate the efficacy of pyrotinib in patients with HER2-mutated/amplified metastatic solid tumors after failure of standard therapy; 2. Secondary objectives: To observe and evaluate the safety of pyrotinib in patients in HER2 mutated or amplified metastatic solid tumors after failure of standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single arm, open-label Phase II clinical study. | Experimental | All subjects enrolled will receive the following treatment:Pyrotinib±standard treatment. Pyrotinib 400 mg/ D (once a day, at the same time each day) until the progression of disease; Chemotherapy regimens follow the programme cycle recommended by the guidelines or as determined by the investigator. The dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects will continue to take medication until completion of the prescribed course of treatment, disease progression, toxicity intolerance, withdrawal of Informed Consent Form, or termination in the investigator's judgment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyrotinib Maleate | Drug | Pyrotinib ± standard regimen Pyrotinib: 400 mg/day (once a day, orally at the same time every day), continued until disease progression; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Defined as proportion of complete response and partial response according to RECIST 1.1 criteria. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death. | 24 months |
| Disease control rate | the proportion of patients whose tumors shrink or remain stable for a certain period of time, including complete remission (CR), partial remission (PR) and stable (SD) cases |
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Inclusion Criteria:
(1) Blood routine: ANC ≥ 1.5×10^9/L; PLT ≥ 90×10^9/L; Hb ≥ 90 g/L; (2) Blood biochemistry: TBIL<=1.5×ULN; ALT and AST<=2×ULN; for subjects with liver metastases, ALT and AST<=5×ULN; BUN and Cr<=1.5×ULN and creatinine clearance ≥50mL/min (Cockcroft-Gault formula); (3) Heart color Doppler ultrasound: LVEF≥50%; (4) 12-lead electrocardiogram: The QT interval (QTcF) corrected by Fridericia's method is <450ms for males and <470ms for females.
10. Have sufficient bone marrow, liver and kidney functions. 11. Women of childbearing age and their spouses are willing to contraception during treatment and within 1 year after the last medication.
Volunteer to join the study, sign an informed consent form, have good compliance and are willing to cooperate with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| li xiao, phd | Contact | 13906036392 | xiaolibohan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| li xiao | Zhongshan Hospital Affiliated to Xiamen University | Principal Investigator |
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| standard regimen | Other | standard regimen |
|
| 24 months |
| Progression-free survival | Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. | 24 months |