Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Antibodies

Antibodies, Monoclonal

Paclitaxel

Trastuzumab

Apatinib

Albumin-Bound Paclitaxel

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Topoisomerase I Inhibitors

Enzyme Inhibitors

Protein Kinase Inhibitors

Antineoplastic Agents, Immunological

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).

Participants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral.

RC48-ADC

Administered according to label, as one option for Physician's Choice (determined before randomization)

Paclitaxel injection

Irinotecan Hydrochloride Injection

Apatinib Mesylate Tablets

Jianmin Fang, PhD

Lin Shen

Aimin Zang

Liqun Jia

Dong Yan

Yingjiang Ye

Ying Cheng

Shan Zeng

Qingshan Li

Jun Zhang

Nanfeng Fan

Dong Ma

Min Shi

Shirong Cai

Yanhong Deng

Nong Xu

Fuming Qiu

Jie'er Ying

Yuxian Bai

Yifu He

Yueyin Pan

Meili Sun

Changzheng Li

Lei Han

Ning Liu

Hao Chen

Zhen Li

Jia Wei

Jianwei Lu

Yongqian Shu

Wensheng Qiu

Xianbao Zhan

Tianshu Liu

Yi Jiang

Jingdong Zhang

Ruilian Xu

Kai Chen

Mudan Yang

Yi Ba

Guohua Yu

Airong Wang

Xianglin Yuan

Enxiao Li

Jiayi Li

Junhui Zhao

Yujuan Qi

Liuzhong Yang

Chao gao

Yuan Yuan

Xizhi Zhang

Liangming Zhang

Suxia Luo

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.

This study is a phase III multi-center, randomized, open-label, parallel control study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of HER2-overexpression locally advanced or metastatic gastric cancer. The HER2-overexpression is defined as: the HER2 IHC 3+ or 2+, regardless of FISH status.

A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression

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

Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.

Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.

The objective response rate will be mainly analyzed by the independent efficacy evaluation committee according to the RECIST 1.1 standard tumor evaluation (the evaluation by the investigator will also be performed).

DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.

Time to disease progression (TTP) refers to the time from the random date to the first disease progression (calculated by the event that occurred first). Disease progression will be evaluated by the investigator according to the RECIST 1.1 standard (investigator and Independent Review Committee(IRC) evaluation).

RemeGen Co., Ltd.

This study will evaluate the efficacy and safety of intravenous RC48-ADC in local advanced or metastatic gastric patients with the overexpression of HER2.

A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2

A Multicenter, Open Label，Single Arm，Phase II Study to Evaluate the Effect and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in HER2 Overexpressing Local Advanced or Metastatic Gastric Cancer

Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

Tumor response was assessed by investigator according to RECIST v1.1

OS was defined as the time from the first study treatment to the date of death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression	NCT04714190	Gastric Cancer HER2 Overexpres...	RC48-ADC Paclitaxel inje... Irinotecan Hydr... Apatinib Mesyla...	18 Years -	RemeGen Co., Ltd.
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression	NCT04714190	Gastric Cancer HER2 Overexpres...	RC48-ADC Paclitaxel inje... Irinotecan Hydr... Apatinib Mesyla...	18 Years -	RemeGen Co., Ltd.
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2	NCT03556345	Gastric Cancer HER2 Overexpres...	RC48-ADC	18 Years - 70 Years	RemeGen Co., Ltd.

Spots Global Cancer Trial Database for her2 overexpressing gastric carcinoma