A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

Last updated: January 10, 2025
Sponsor: Shanghai Henlius Biotech
Overall Status: Active - Recruiting

Phase

3

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

HLX22

Trastuzumab

Oxaliplatin

Clinical Study ID

NCT06532006
HLX22-GC-301
  • Ages > 18
  • All Genders

Study Summary

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male/female who are at least 18 years of age on the day of signing the informedconsent.

  2. With histologically or cytologically confirmed diagnosis of previously untreated,locally advanced unresectable or metastatic HER2-positive gastric orgastroesophageal junction adenocarcinoma.

  3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the targetlesion must not be a bone metastatic lesion only.

  4. HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ orFISH, as assessed by a central laboratory on a primary or metastatic tumor.

  5. ECOG PS within 7 days before randomization: 0-1.

  6. Expected survival ≥ 6 months.

  7. Had adequate organ function

Exclusion

Exclusion Criteria:

  1. Patients with other malignant tumors within 2 years before the randomization.

  2. Evidence of disease progression within 6 months (before randomization) aftercompletion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapyfor gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.

  3. Previous treatment with any HER2-target therapy.

  4. Active gastrointestinal bleeding

  5. Presence of central nervous system (CNS) metastases.

  6. Left ventricular ejection fraction (LVEF) < 55%.

  7. Subjects who had known history of severe allergy to any monoclonal antibody or anycomponent of study treatment.

Study Design

Total Participants: 550
Treatment Group(s): 5
Primary Treatment: HLX22
Phase: 3
Study Start date:
November 22, 2024
Estimated Completion Date:
September 01, 2028

Study Description

In experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), once every 3 weeks (Q3W).

In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijia Zhuang, Hebei
    China

    Active - Recruiting

  • Affiliated Hospital of Youjiang Medical University for Nationalities

    BaiSe,
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    BeiJing,
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    BengBu,
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    ChangChun,
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    ChangSha,
    China

    Active - Recruiting

  • Heping Hospital Affiliated to Changzhi Medical College

    ChangZhi,
    China

    Active - Recruiting

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    ChengDu,
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    ChongQing,
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou,
    China

    Active - Recruiting

  • Zhongshan City People's Hospital

    GuangDong,
    China

    Active - Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou,
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine

    HangZhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medic

    Hangzhou,
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    HeFei,
    China

    Active - Recruiting

  • The Second Hospital of Anhui Medical University

    HeFei,
    China

    Active - Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan,
    China

    Active - Recruiting

  • Gansu Provincial Cancer Hospital

    LanZhou,
    China

    Active - Recruiting

  • Gansu Provincial Hospital

    Lanzhou,
    China

    Active - Recruiting

  • The First Hospital Of Lanzhou University

    Lanzhou,
    China

    Active - Recruiting

  • Liuzhou Workers' Hospital

    Liuzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science

    Luoyang,
    China

    Active - Recruiting

  • Mianyang Central Hospital

    MianYang,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    NanChang,
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing,
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao,
    China

    Active - Recruiting

  • Renji Hospital,Shanghai Jiao Tong University School of Medicine

    Shanghai,
    China

    Active - Recruiting

  • The Central Hospital of Shaoyang

    ShaoYang,
    China

    Active - Recruiting

  • Liaoning Medical University Cancer Institute & Hospital

    Shenyang,
    China

    Active - Recruiting

  • Shanxi Cancer Hospital

    Taiyuan,
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin,
    China

    Active - Recruiting

  • Cancer Hospital Affiliated to Xinjiang Medical University

    Urumqi,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xiamen University

    XiaMen,
    China

    Active - Recruiting

  • Qinghai University Affiliated Hospital

    Xining,
    China

    Active - Recruiting

  • Xuzhou Central Hospital

    XuZhou,
    China

    Active - Recruiting

  • Yichang Central People's Hospital

    YiChang,
    China

    Active - Recruiting

  • General Hospital of Ningxia Medical University

    YinChuan,
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Active - Recruiting

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima-shi,
    Japan

    Active - Recruiting

  • Ishikawa Prefectural Central Hospital

    Kanazawa-shi,
    Japan

    Active - Recruiting

  • Osaki Citizen Hospital

    Osaki-shi,
    Japan

    Active - Recruiting

  • Keiyukai Sapporo Hospital

    Sapporo-shi,
    Japan

    Active - Recruiting

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