Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Gastric Cancer With HER2-overexpression

Who is this study for? Patients with Gastric Cancer
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression locally advanced or metastatic gastric cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Voluntary agreement to provide written informed consent.

• 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.

Locations
Other Locations
China
Affiliated Hospital of Hebei University
RECRUITING
Baoding
Beijing Cancer Hospital
RECRUITING
Beijing
China-Japan Friendship Hospital
RECRUITING
Beijing
Luhe Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Jilin Provincial Tumor Hospital
RECRUITING
Changchun
Xiangya Hospital of Central South University
RECRUITING
Changsha
Affiliated Hospital of Chengde Medical College
RECRUITING
Chengde
Three Gorges Hospital Affiliated to Chongqing University
RECRUITING
Chongqing
Fujian Cancer Hospital
RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Southern Hospital of Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
The Sixth Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
The Affiliated Tumor Hospital of Harbin Medical University
RECRUITING
Harbin
Anhui Cancer Hospital
RECRUITING
Hefei
Anhui Provincial Hospital
RECRUITING
Hefei
Jinan Central Hospital
RECRUITING
Jinan
Shandong Cancer Hospital
RECRUITING
Jinan
Affiliated Hospital of Jining Medical College
RECRUITING
Jining
The First People's Hospital of Jining City
RECRUITING
Jining
Lanzhou University Second Hospital
RECRUITING
Lanzhou
Linyi Tumor Hospital
RECRUITING
Linyi
Drum Tower Hospital Affiliated to Nanjing University School of Medicine
RECRUITING
Nanjing
Jiangsu Cancer Hospital
RECRUITING
Nanjing
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
RECRUITING
Nanjing
Qingdao University Hospital
RECRUITING
Qingdao
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shanghai Changhai Hospital
RECRUITING
Shanghai
Zhongshan Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Cancer Hospital Affiliated to Shantou University Medical College
RECRUITING
Shantou
Liaoning Cancer Hospital
RECRUITING
Shenyang
Shenzhen People's Hospital
RECRUITING
Shenzhen
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Shanxi Cancer Hospital
RECRUITING
Taiyuan
Tianjin Cancer Hospital
RECRUITING
Tianjin
Weifang People's Hospital
RECRUITING
Weifang
Weihai Municipal Hospital
RECRUITING
Weihai
Huazhong University of Science Tongji Hospital, Tongji Medical College
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Affiliated Hospital of Qinghai University
RECRUITING
Xining
Qinghai Provincial People's Hospital
RECRUITING
Xining
The First Affiliated Hospital of Xinxiang Medical College
RECRUITING
Xinxiang
Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Xuzhou Central Hospital
RECRUITING
Xuzhou
Subei People's Hospital of Jiangsu Province
RECRUITING
Yangzhou
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Jianmin Fang, PhD
jianminfang@hotmail.com
010-58075561
Time Frame
Start Date: 2021-03-24
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 351
Treatments
Experimental: 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).
Active_comparator: Physician's Choice
Participants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral.
Related Therapeutic Areas
Sponsors
Leads: RemeGen Co., Ltd.

This content was sourced from clinicaltrials.gov