An observational study in HER2, Advanced Gastric Cancer and Advanced Gastroesophageal Junction Adenocarcinoma, sponsored by Shen Lin. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-16.
Sponsored by Shen Lin · Observational
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).
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 306 is above the median of 153 across 332 observational studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Shen Lin is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Patients with advanced solid tumors with HER2 overexpression after previous first-line standard therapy failure
Exclusion Criteria:
Cohort1: About 186 patients with histologically or cytologically confirmed gastric/gastroesophageal junction (GEJ) adenocarcinoma with HER2 overexpression who received a regimen containing Disitamab Vedotin;
Drug: Disitamab Vedotin
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;
Drug: Disitamab Vedotin
Cohort3: Approximately 40 patients with other advanced solid tumors histologically or cytologically confirmed with HER2-overexpression and receiving a regimen containing Disitamab Vedotin.
Drug: Disitamab Vedotin
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.
Also known as: RC48
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.
Time frame: From January 2023 to January 2025
Incidence, drug correlation, and severity of adverse events during the study period
Incidence, drug correlation, and severity of adverse events during the study period
Time frame: From January 2023 to January 2025
Overall survival (OS)
Time from the start of administration to death from any cause
Time frame: 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
Time frame: 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
Time frame: From January 2023 to January 2025
This study is not yet recruiting, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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