Clinical trial NCT05318339: A Study of Trastuzumab and Pyrotinib in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma
Official title: Open-label, Single-arm Phase II Study of Trastuzumab and Pyrotinib Combination Regimen in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma Refractory to Standard Therapies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Transitional Cell
HER-2 Gene Amplification
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2022-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A open-label, single-arm, phase II trial to study was designed to evaluate the effectiveness and safety of trastuzumab and pyrotinib in treating HER2 positive patients who have previously treated, locally advanced, or metastatic urothelial carcinoma.


Eligibility criteria: Inclusion Criteria:

* Sign the informed consent form
* Locally advanced or metastatic histologically confirmed transitional cell carcinoma of the urothelium, including the bladder, urethra, ureter, or renal pelvis
* 18 years and older
* HER2 expression (3+ or 2+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization
* Relapsed from or failed at least one prior standard systemic chemotherapy regimen, including immunotherapy, HER2 ADC durgs, and chemothearpy containing cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine
* At least 1 measurable lesion could be evaluated by RECIST v1.1
* Performance status: ECOG 0-1
* Life expectancy more than 12 weeks
* Ejection fraction at least 50% (or lower limit of normal) by echocardiogram
* Good organ function:

Blood routine: hemoglobin ≥80g/L, neutrophil ≥1.5×10\^9/L, platelet ≥75×10\^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL, ALT≤5×UNL and AST≤5×UNL for patients with liver metastasis

Exclusion Criteria:

* Have received trastuzumab or pyrotinib treatment in the past
* Known to have allergic reactions to any ingredients or excipients of experimental drugs
* Radiotherapy, RFA, interventional therapy or surgery were performed within 28 days before the first medication (except for previous diagnostic biopsy)
* Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment
* Clinically significant ascites
* Brain metastasis or meningeal metastasis with neurological symptoms
* Diabetes was not controlled, defined as HbA1c \> 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure \> 140 / 90 mmHg after antihypertensive drug
* Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months
* Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C
* Pregnant or nursing
* May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results
* There are other serious diseases that the researchers believe patients cannot be included in the study

Primary outcomes:
measure: ORR
timeFrame: 1 year
Secondary outcomes:
measure: OS
timeFrame: From date of initiation of treatment to date of death due to any cause, assessed up to 2 years
measure: PFS
timeFrame: From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
References: