Clinical trial NCT06846996: Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
Official title: Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China: A Nation-wide, Multi-center, Prospective, Non-interventional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HER2-positive Gastric Cancer
HER2-positive Gastroesophageal Junction
Keywords: HER2-positive gastric cancer
HER2-positive gastroesophageal junction
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants for this study include participants with HER2-positive local advanced or metastatic GC/GEJA.

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.

Eligibility criteria: Participants must meet all the following inclusion criteria to be eligible for the study:

1. Participants with pathologically diagnosed locally advanced unresectable or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJA).
2. ≥18 years of age at the time of starting the first dose of T-DXd and signing informed consent form (ICF), capable of providing informed consent.
3. HER2-positive status (IHC 3+ or IHC 2+/ISH +).
4. Received prior anti-cancer treatment regimens according to National Medical Products Administration indication or clinical judgement of physician.
5. Decision to newly initiate T-DXd before study ICF signing. If the participants have started the first dose of T-DXd no longer than 21 days before enrollment, they could be enrolled if the signed and dated ICF could be obtained.

Exclusion Criteria：

Participants who meet any of the following criteria will be excluded from the study:

1. Pregnancy or breastfeeding.
2. Participants who at the time of data collection of the study are participating in or have participated in an interventional study that remains blinded.
3. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
4. Judged by the investigator to be unfit to participate in the study.

Primary outcomes:
measure: Real-world Time to Treatment Failure (rwTTF)
timeFrame: 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
Secondary outcomes:
measure: Number of Participants Reporting Treatment Related Adverse Events (TRAE) and Physician-reported Adverse Event of Special Interest (AESI), Regardless of Grade
timeFrame: 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
measure: Real-world Time to Next Treatment (rwTTNT)
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing GoBroad Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changzhi
country: China
facility: Changzhi People's Hospital
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital and Institute of Guangzhou Medical University
city: Guangzhou
country: China
facility: Guangdong Hospital of Traditional Chinese Medicine
city: Haikou
country: China
facility: Hainan General Hospital
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
city: Hefei
country: China
facility: Anhui Province Cancer Hoospital
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai
country: China
facility: Shanghai GoBroad Cancer Hospital
city: Shanghai
country: China
facility: Shanghai ninth People's Hospital,Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Xi'an
country: China
facility: The Affiliated Hospital of Xi'an Jiaotong University
city: Xiamen
country: China
facility: The Affiliated Hospital of Xiamen University
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Daiichi Sankyo (China) Holdings Co., Ltd.
name: Project Manager
role: STUDY_DIRECTOR
References: