Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HE… (NCT04215159) | Clinical Trial Compass
UnknownPhase 2
Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Solid Tumor
42 participantsStarted 2019-12-30
Plain-language summary
HER2 signaling pathway abnormalities or HER2 overexpression can be seen in various types of solid tumors apart from breast cancer or hepatic cancer. In this regardHER2 targeting therapy has been proven to be effective in colorectal cancer, gallbladder cancer, and salivary gland tumors. Although HER2 targeted-treatment Trastuzumab biosimilar is clinically being used after gaining official permission recently, clinical data for this use is still lacking, especially regarding experiences of combination with various cytotoxic chemotherapy agents.
Notably, techniques to separate and extract a small sized ciculating tumor DNA (ctDNA) in patient's blood originated from a tumor is being developed and improved along with introduction of Next-generation sequencing (NGS) technique enabling a comprehensive genetic testing.
The aim of this study is to evaluate the efficacy and safety of Trastuzumab biosimiler and to investigate the association between ctDNA and clinical outcomes such as disease response, progression-free survival, and overall survival.
Who can participate
Age range19 Years – 79 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed HER2 -overexpression (HER2 overexpression defined as 3+ positive by immunohistochemistry, positive by fluorescence in situ hybridization (FISH), or confirmation of HER2 amplification). However hepatic cancer and breast cancer are exclude as HER2 targeted treatment is already a standard treatment for these tumor types.
* Patients who have progressed after at least one standard treatment or unable to continue standard treatment due to adverse events.
* Patients confirmed as metastatic or unresectable cancer by imaging test
* At least one measurable lesion that can be accurately assessed by imaging according to RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry
* Adequate organ function (bone marrow, liver, kidney function) A. ANC ≥ 1000/mL B.Platelets ≥ 75,000/uL C.Hemoglobin \>8.0 g/dL D.Total bilirubin ≤ 2.0x ULN E.AST and ALT \< 5.0 x ULN F.Alkaline phosphatase \<2.5x ULN GCreatinine ≤ 2.0x ULN or CCr \>30 ml/min
* Estimated life expectancy of more than 3 months
* Left ventricular ejection fraction of at least ≥ 50% at trial entry
* Age ≥19 years who have signed an informed consent approved by Institutional Review Board of Organization
Exclusion Criteria:
* Either woman of pregnancy or breast-feeding woman who is positive for hCG
* Symptomatic or unstable metastases to central nervous system (exceptions : properly treated brain metastasis with no evidence of pr…