Real-world Study of HER2-overexpressed Advanced Solid Tumors After Progression of First-line Standard Therapy
NCT ID: NCT05649163
Last Updated: 2022-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
306 participants
OBSERVATIONAL
2023-01-31
2025-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* To evaluate the real-world safety and efficacy of Disitamab Vedotin in second-line and beyond treatment of advanced solid tumors with HER2 overexpression
* To describe the treatment pattern and clinical outcomes of patients with advanced gastric cancer with HER2 overexpression in real world Settings after the failure of first-line standard therapy.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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;
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.
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;
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.
Cohort3
Cohort3: Approximately 40 patients with other advanced solid tumors histologically or cytologically confirmed with HER2-overexpression and receiving a regimen containing Disitamab Vedotin.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥18 years old, gender unlimited;
* ECOG physical status 0-2 points;
* Patients with locally advanced or metastatic solid tumors confirmed histologically or cytologically;Cohort1-2 cohort: patients who had received at least previous first-line standard therapy (HER2 IHC3+ or IHC2+/FISH+ patients with first-line trastuzumab (or its biosimilar) combined with chemotherapy (fluorouracil and/or platinum-based chemotherapy);IHC2+/FISH- patients with first-line Immunotherapy combined with chemotherapy (fluorouracil and/or platinum-based chemotherapy) or chemotherapy alone);In Cohort3 cohort, patients received at least the standard first-line treatment clearly recommended by the guidelines. Patients with clear disease progression confirmed by the investigator or documented history.
* HER2 overexpression was defined as 2+ or 3+ immunohistochemistry (both primary and metastatic tumor tissue were acceptable), and previous patient test results (confirmed by the investigator) or center test results were acceptable.
* Have measurable or evaluable lesions according to RECIST1.1 criteria;
* The investigator evaluated that the patients would benefit from the study treatment;
* Good compliance, willing and able to follow the trial and follow-up procedures;
* Have traceable patient medical records.
Exclusion Criteria
* Participating in any interventional clinical trials;
* The investigator assessed inappropriate inclusion.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RemeGen Co., Ltd.
INDUSTRY
Shen Lin
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shen Lin
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lin Shen, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lin Shen, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DVReal-001
Identifier Type: -
Identifier Source: org_study_id