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Real-world Study of HER2-overexpressed Advanced Solid Tumors After Progression of First-line Standard Therapy

NCT05649163 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 306

Last updated 2022-12-16

No results posted yet for this study

Summary

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:

* 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.

Conditions

  • HER2
  • Advanced Gastric Cancer
  • Advanced Gastroesophageal Junction Adenocarcinoma
  • Advanced Solid Tumor

Interventions

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.

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    collaborator INDUSTRY

  • Shen Lin

    lead OTHER

Principal Investigators

  • Lin Shen, MD · Peking University Cancer Hospital & Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2025-01-31
Completion
2025-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05649163 on ClinicalTrials.gov