NCT05649163

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

A Non-interventional, Multi-cohort, Multi-center, Prospective Real-world Study of Treatment Pattern and Clinical Outcomes in Patients With HER2-overexpressed Advanced Solid Tumors After Progression of First-line Standard Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 306 (estimated)
• Sponsor: Shen Lin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-01-01
• Completion: 2025-05-01
• First posted: 2022-12-13
• Last updated: 2022-12-16

Locations

1 site across 1 country: China