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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05649163
• Other study ID #: DVReal-001
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: May 2025

Study information

• Verified date: December 2022
• Source: Peking University
• Contact: Lin Shen, MD
• Phone: 86-010-88196561
• Email: doctorshenlin[@]sina.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 306
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signing informed consent and agreeing to comply with study requirements;

• 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:

• Known hypersensitivity or delayed allergic reactions to certain components of the study drug or similar drugs;

• Participating in any interventional clinical trials;

• The investigator assessed inappropriate inclusion.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Shen Lin	RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Overall survival (OS)	Time from the start of administration to death from any cause	From January 2023 to January 2025
Secondary	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
Secondary	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