Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China

Recruiting

• Conditions: HER2-positive Gastric Cancer; HER2-positive Gastroesophageal Junction
• Interventions: Drug: Trastuzumab deruxtecan (T-DXd)

• Registration Number: NCT06846996
• Lead Sponsor: Daiichi Sankyo

Brief Summary

Trastuzumab deruxtecan's (T-DXd's) efficacy and safety has been confirmed in traditional clinical trials, there is a lack of real-world evidence, especially among Chinese patients. The objective of this study is to evaluate real-world effectiveness and safety profile of T-DXd by collecting real-world data treating in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Detailed Description

The primary objective of this study is to evaluate the effectiveness of T-DXd in real-world setting (real-word time to treatment failure).

The secondary objectives of this study are to assess the safety profile of T-DXd (treatment related adverse events \[TRAE\] regardless of grade, and physician reported adverse events of special interest \[AESI\] regardless of grade, etc.) and to evaluate effectiveness of T-DXd (real-world time to next treatment). This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on T-DXd will be enrolled in this study.

Study Timeline

• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Study First Posted: 2025-02-26
• Study Start: 2025-02-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HER2-positive gastric/gastroesophageal junction adenocarcinoma	Trastuzumab deruxtecan (T-DXd)	Patients who are diagnosed with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who made a decision (prior to enrolling in this study) to receive T-DXd treatment in a clinical practice setting.

Primary Outcome Measures

Name	Time	Method
Real-world Time to Treatment Failure (rwTTF)	T-DXd treatment initiation date (index date) to date of treatment discontinuation due to disease progression, physician decision, adverse events or death, whichever occurs first, up to approximately 2 years	rwTTF is defined as time from T-DXd treatment initiation date to the earliest date of treatment discontinuation due to disease progression, physician decision, adverse events or death.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Treatment Related Adverse Events (TRAE) and Physician-reported Adverse Event of Special Interest (AESI), Regardless of Grade	T-DXd treatment initiation date (index date) until end of study, or death, or withdrawal of consent, or loss to follow-up (LTFU), or study closure, whichever occurs first, up to approximately 2 years	A TRAE is defined as a harmful reaction, resulting from the normal usage and dosage to a medicinal product, which is unrelated to the purpose of medication. Physician-reported AESIs are defined as interstitial lung disease/pneumonitis and left ventricular ejection fraction decrease.
Real-world Time to Next Treatment (rwTTNT)	T-DXd treatment initiation date (index date) to the date of receiving next line anti-cancer treatment or death, whichever occurs first, up to approximately 2 years	rwTTNT is defined as time from T-DXd treatment initiation date to the earliest date of receiving next line anti-cancer treatment, or death.

Trial Locations

Locations (36)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Beijing GoBroad Hospital; 🇨🇳 Beijing, China

The First Hospital of Jilin University; 🇨🇳 Changchun, China

Changzhi People's Hospital; 🇨🇳 Changzhi, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, China

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, China

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