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

Last updated: March 5, 2025
Sponsor: Daiichi Sankyo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Digestive System Neoplasms

Adenocarcinoma

Treatment

No drug

Trastuzumab deruxtecan (T-DXd)

Clinical Study ID

NCT06846996
DS8201-0076-NIS-MA
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 260
Treatment Group(s): 2
Primary Treatment: No drug
Phase:
Study Start date:
February 27, 2025
Estimated Completion Date:
July 31, 2027

Study 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).

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, 100032
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, 100034
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, 130031
    China

    Site Not Available

  • Changzhi People's Hospital

    Changzhi, 046000
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, 350000
    China

    Site Not Available

  • Guangdong Hospital of Traditional Chinese Medicine

    Guangzhou, 510120
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080
    China

    Site Not Available

  • Hainan General Hospital

    Haikou, 570100
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310009
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, 310005
    China

    Site Not Available

  • Anhui Province Cancer Hoospital

    Hefei, 236000
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, 210000
    China

    Site Not Available

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, 201104
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200127
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200025
    China

    Site Not Available

  • Shanghai GoBroad Cancer Hospital

    Shanghai, 200003
    China

    Site Not Available

  • Shanghai ninth People's Hospital,Shanghai Jiaotong University School of Medicine

    Shanghai, 200011
    China

    Site Not Available

  • Zhongshan Hospital

    Shanghai, 200032
    China

    Site Not Available

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515000
    China

    Site Not Available

  • Liaoning Cancer Hospital

    Shenyang, 110000
    China

    Site Not Available

  • The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)

    Shijiazhuang, 050010
    China

    Site Not Available

  • Shanxi Cancer Hospital

    Taiyuan, 030000
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Taizhou, 317700
    China

    Site Not Available

  • The Second Hospital of Tianjin Medical University

    Tianjin, 300211
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300000
    China

    Site Not Available

  • The Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061
    China

    Site Not Available

  • The Affiliated Hospital of Xiamen University

    Xiamen, 361003
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 221006
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450066
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.