A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
- Conditions
- Gastric CancerHER2-positive Gastric CancerGastroesophageal-junction CancerMonoclonal Antibody
- Interventions
- Registration Number
- NCT06532006
- Lead Sponsor
- Shanghai Henlius Biotech
- Brief 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
- Male/female who are at least 18 years of age on the day of signing the informed consent.
- With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
- Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
- HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor.
- ECOG PS within 7 days before randomization: 0-1.
- Expected survival ≥ 6 months.
- Had adequate organ function
- Patients with other malignant tumors within 2 years before the randomization.
- Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
- Previous treatment with any HER2-target therapy.
- Active gastrointestinal bleeding
- Presence of central nervous system (CNS) metastases.
- Left ventricular ejection fraction (LVEF) < 55%.
- Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group HLX22 Experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), Q3W Subjects in the experimental group may use one of the treatments below: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) or HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) + placebo (for pembrolizumab) Experimental group Trastuzumab Experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), Q3W Subjects in the experimental group may use one of the treatments below: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) or HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) + placebo (for pembrolizumab) Experimental group Oxaliplatin Experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), Q3W Subjects in the experimental group may use one of the treatments below: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) or HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) + placebo (for pembrolizumab) Experimental group Capecitabine Experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), Q3W Subjects in the experimental group may use one of the treatments below: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) or HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) + placebo (for pembrolizumab) Control group Pembrolizumab Control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W Subjects in the control group may use one of the treatments below: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) or Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) + pembrolizumab Control group Oxaliplatin Control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W Subjects in the control group may use one of the treatments below: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) or Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) + pembrolizumab Control group Capecitabine Control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W Subjects in the control group may use one of the treatments below: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) or Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) + pembrolizumab Control group Trastuzumab Control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W Subjects in the control group may use one of the treatments below: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) or Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) + pembrolizumab
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee) Up to 5 years PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
Overall Survival （OS） Up to 5 years OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.
- Secondary Outcome Measures
Name Time Method PFS per RECIST 1.1 assessed by investigator Up to 5 years PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1 Up to 5 years ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1. ORR will be determined for each treatment arm.
Adverse events (AE) Up to 5 years An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm.
Trial Locations
- Locations (47)
The Fourth Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, Hebei, China
Affiliated Hospital of Youjiang Medical University for Nationalities
🇨🇳BaiSe, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳BeiJing, China
The First Affiliated Hospital of Bengbu Medical University
🇨🇳BengBu, China
The First Hospital of Jilin University
🇨🇳ChangChun, China
Hunan Cancer Hospital
🇨🇳ChangSha, China
Heping Hospital Affiliated to Changzhi Medical College
🇨🇳ChangZhi, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
🇨🇳ChengDu, China
West China Hospital of Sichuan University
🇨🇳Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳ChongQing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China
Zhongshan City People's Hospital
🇨🇳GuangDong, China
The Sixth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, China
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
🇨🇳HangZhou, China
The First Affiliated Hospital, Zhejiang University School of Medic
🇨🇳Hangzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳HeFei, China
The Second Hospital of Anhui Medical University
🇨🇳HeFei, China
Cancer Hospital of Shandong First Medical University
🇨🇳Jinan, China
Gansu Provincial Cancer Hospital
🇨🇳LanZhou, China
Gansu Provincial Hospital
🇨🇳Lanzhou, China
The First Hospital Of Lanzhou University
🇨🇳Lanzhou, China
Liuzhou Workers' Hospital
🇨🇳Liuzhou, China
The First Affiliated Hospital of Henan University of Science
🇨🇳Luoyang, China
Mianyang Central Hospital
🇨🇳MianYang, China
The First Affiliated Hospital of Nanchang University
🇨🇳NanChang, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China
Renji Hospital,Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
The Central Hospital of Shaoyang
🇨🇳ShaoYang, China
Liaoning Medical University Cancer Institute & Hospital
🇨🇳Shenyang, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, China
Cancer Hospital Affiliated to Xinjiang Medical University
🇨🇳Urumqi, China
The First Affiliated Hospital of Xiamen University
🇨🇳XiaMen, China
Qinghai University Affiliated Hospital
🇨🇳Xining, China
Xuzhou Central Hospital
🇨🇳XuZhou, China
Yichang Central People's Hospital
🇨🇳YiChang, China
General Hospital of Ningxia Medical University
🇨🇳YinChuan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Hiroshima City Hiroshima Citizens Hospital
🇯🇵Hiroshima-shi, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa-shi, Japan
Osaki Citizen Hospital
🇯🇵Osaki-shi, Japan
Keiyukai Sapporo Hospital
🇯🇵Sapporo-shi, Japan
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China