A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression
NCT ID: NCT04714190
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
351 participants
INTERVENTIONAL
2021-03-24
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RC48-ADC
Participants will receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
RC48-ADC
2.5 mg/kg IV every 2 weeks
Physician's Choice
Participants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral.
Paclitaxel injection
Administered according to label, as one option for Physician's Choice (determined before randomization)
Irinotecan Hydrochloride Injection
Administered according to label, as one option for Physician's Choice (determined before randomization)
Apatinib Mesylate Tablets
Administered according to label, as one option for Physician's Choice (determined before randomization)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RC48-ADC
2.5 mg/kg IV every 2 weeks
Paclitaxel injection
Administered according to label, as one option for Physician's Choice (determined before randomization)
Irinotecan Hydrochloride Injection
Administered according to label, as one option for Physician's Choice (determined before randomization)
Apatinib Mesylate Tablets
Administered according to label, as one option for Physician's Choice (determined before randomization)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male or female, Age ≥ 18 years.
* Predicted survival ≥ 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
* Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
* Adequate organ function.
* All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma
* Have had progression or intolerance following receipt of at least two systemic chemotherapy for advanced or metastatic disease.
* The HER2 IHC test result is IHC 2+ or IHC 3+, the subject's previous test results (confirmed by the investigator) or the research center's test results are acceptable; the subject can provide the Specimen of primary or metastatic tumor for HER2 review/judgment.
* HER2 classic positive (definition: IHC3+ or IHC2+FISH+) and patients who have previously failed standard treatment
* According to the RECIST 1.1 standard, there is at least one measurable lesion.
Exclusion Criteria
* History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
* History of major surgery within 4 weeks of planned start of trial treatment.
* Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RemeGen Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Affiliated Hospital of Hebei University
Baoding, , China
China-Japan Friendship Hospital
Beijing, , China
Luhe Hospital Affiliated to Capital Medical University
Beijing, , China
Peking University People's Hospital
Beijing, , China
Jilin Provincial Tumor Hospital
Changchun, , China
Xiangya Hospital of Central South University
Changsha, , China
Affiliated Hospital of Chengde Medical College
Chengde, , China
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, , China
Fujian Cancer Hospital
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Southern Hospital of Southern Medical University
Guangzhou, , China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, , China
Anhui Cancer Hospital
Hefei, , China
Anhui Provincial Hospital
Hefei, , China
Jinan Central Hospital
Jinan, , China
Shandong Cancer Hospital
Jinan, , China
Affiliated Hospital of Jining Medical College
Jining, , China
The First People's Hospital of Jining City
Jining, , China
Lanzhou University Second Hospital
Lanzhou, , China
Linyi Tumor Hospital
Linyi, , China
Drum Tower Hospital Affiliated to Nanjing University School of Medicine
Nanjing, , China
Jiangsu Cancer Hospital
Nanjing, , China
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, , China
Qingdao University Hospital
Qingdao, , China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, , China
Shanghai Changhai Hospital
Shanghai, , China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, , China
Cancer Hospital Affiliated to Shantou University Medical College
Shantou, , China
Liaoning Cancer Hospital
Shenyang, , China
Shenzhen People's Hospital
Shenzhen, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Shanxi Cancer Hospital
Taiyuan, , China
Tianjin Cancer Hospital
Tianjin, , China
Weifang People's Hospital
Weifang, , China
Weihai Municipal Hospital
Weihai, , China
Huazhong University of Science Tongji Hospital, Tongji Medical College
Wuhan, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Affiliated Hospital of Qinghai University
Xining, , China
Qinghai Provincial People's Hospital
Xining, , China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, , China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, , China
Xuzhou Central Hospital
Xuzhou, , China
Subei People's Hospital of Jiangsu Province
Yangzhou, , China
Yantai Yuhuangding Hospital
Yantai, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lin Shen
Role: primary
Aimin Zang
Role: primary
Liqun Jia
Role: primary
Dong Yan
Role: primary
Yingjiang Ye
Role: primary
Ying Cheng
Role: primary
Shan Zeng
Role: primary
Qingshan Li
Role: primary
Jun Zhang
Role: primary
Nanfeng Fan
Role: primary
Dong Ma
Role: primary
Min Shi
Role: primary
Shirong Cai
Role: primary
Yanhong Deng
Role: primary
Nong Xu
Role: primary
Fuming Qiu
Role: primary
Jie'er Ying
Role: primary
Yuxian Bai
Role: primary
Yifu He
Role: primary
Yueyin Pan
Role: primary
Meili Sun
Role: primary
Changzheng Li
Role: primary
Lei Han
Role: primary
Ning Liu
Role: primary
Hao Chen
Role: primary
Zhen Li
Role: primary
Jia Wei
Role: primary
Jianwei Lu
Role: primary
Yongqian Shu
Role: primary
Wensheng Qiu
Role: primary
Jun Zhang
Role: primary
Xianbao Zhan
Role: primary
Tianshu Liu
Role: primary
Yi Jiang
Role: primary
Jingdong Zhang
Role: primary
Ruilian Xu
Role: primary
Kai Chen
Role: primary
Mudan Yang
Role: primary
Yi Ba
Role: primary
Guohua Yu
Role: primary
Airong Wang
Role: primary
Xianglin Yuan
Role: primary
Enxiao Li
Role: primary
Jiayi Li
Role: primary
Junhui Zhao
Role: primary
Yujuan Qi
Role: primary
Liuzhong Yang
Role: primary
Chao gao
Role: primary
Yuan Yuan
Role: primary
Xizhi Zhang
Role: primary
Liangming Zhang
Role: primary
Suxia Luo
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC48-C007
Identifier Type: -
Identifier Source: org_study_id