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| Name | Class |
|---|---|
| RemeGen Co., Ltd. | INDUSTRY |
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The goal of this observational study is to learn about in describe treatment pattern and clinical outcomes in patients with HER2-overexpressed advanced solid tumors after progression of first-line standard therapy. The main questions it aims to answer are:
This is a prospective, non-interventional, multi-cohort, multi-center real-world study to evaluate the treatment pattern and clinical outcomes of patients with advanced HER2-overexpressed solid tumors after the progression of first-line standard therapy. Enrolled subjects in this study were treated according to the treatment protocol established by physicians according to clinical routine. The tests, examinations and drug use in the study were consistent with the requirements of the clinical practice. No additional tests, examinations and drugs were generated from the data collection in this study. The study included 306 patients with HER2-overexpressed advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma and other advanced solid tumors who had failed previous first-line standard therapy. HER2 overexpression was defined as IHC2+ or IHC3+ detected by immunohistochemistry (IHC) (either primary or metastatic tumor tissue).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1 | Cohort1: About 186 patients with histologically or cytologically confirmed gastric/gastroesophageal junction (GEJ) adenocarcinoma with HER2 overexpression who received a regimen containing Disitamab Vedotin; |
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| Cohort2 | Cohort2: About 80 patients with histologically or cytologically confirmed HER2-overexpressed gastric cancer /GEJ adenocarcinoma who received an investigator-selected regimen in addition to Disitamab Vedotin; |
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| Cohort3 | Cohort3: Approximately 40 patients with other advanced solid tumors histologically or cytologically confirmed with HER2-overexpression and receiving a regimen containing Disitamab Vedotin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disitamab Vedotin | Drug | Cohort 1: received a regimen containing Disitamab Vedotin. Cohort 2: received an investigator-selected regimen in addition to Disitamab Vedotin; Treatment options selected by the investigator: no treatment containing Disitamab Vedotin was given, and other systemic antitumor agents (including chemotherapy, such as paclitaxel, docetaxel, irinotecan, and fluorouracil) were selected by the investigator in line with clinical practice. Targeted therapy: such as apatinib, ramucirumab; Combination therapy: ramucirumab + paclitaxel; Immune checkpoint inhibitors such as PD1/PD-L1); Cohort 3: receiving a regimen containing Disitamab Vedotin. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of grade 3 and above adverse events associated with Disitamab Vedotin treatment during the study period. | The incidence of grade 3 and above adverse events associated with Disitamab Vedotin treatment during the study period. | From January 2023 to January 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, drug correlation, and severity of adverse events during the study period | Incidence, drug correlation, and severity of adverse events during the study period | From January 2023 to January 2025 |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced solid tumors with HER2 overexpression after previous first-line standard therapy failure
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen, MD | Contact | 86-010-88196561 | doctorshenlin@sina.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| C000722994 | disitamab vedotin |
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Time from the start of administration to death from any cause
| From January 2023 to January 2025 |
| Progression-free survival (PFS) | The first objective record of disease progression or death from any cause (whichever occurs first) occurred after patients were enrolled and given the drug | From January 2023 to January 2025 |
| Objective response rate (ORR) | Refers to the proportion of patients with an optimal overall response rating of CR or PR | From January 2023 to January 2025 |