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.

Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.

Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.

160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.

200 mg administered as IV infusion on Day 1 of each 21-day cycle.

HX008

Administered as IV infusion on Day 1 of each 21-day cycle.

Placebo

Jing Huang, MD

Zhendong Chen

Guangyu An

Lin Zhao

Bangwei Cao

Baoshan Cao

Jun Liang

Weiqing Chen

Rongbo Lin

Chuan Jin

Jianjun Xiao

Shubin Wang

Chunxia Du

Zhihui Liu

Sheng Ye

Shengmian Li

Na Li

Qingxia Fan

Xinshuai Wang

Shundong Cang

Xianling Liu

Xianli Yin

Zhenping Wen

Yang Ling

Lingjun Zhu

Yang Yang

Cailian Wang

Lei Yang

Zhixiang Zhuang

Jiandong Tong

Xiaojun Xiang

Yiye Wan

Wei Li

Yunpeng Liu

Ping Chen

Weibo Wang

Bo Liu

Jing Lv

Ping Sun

Hongxia Wang

Zan Shen

Lu Wen

Jin Lu

Diansheng Zhong

Xinjun Liang

Wenran Wang

Yong Tang

Qing Bi

Yi Zheng

Liqin Lu

Hongming Pan

Haijun Zhong

Zhiming Huang

This is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety of HX008 injection combined with irinotecan versus placebo combined with irinotecan as second-line therapy in patients with adcanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have had tumor progression after first-line treatment with platinum and/or fluropyrimidine therapy.

HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HX008 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm.

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm with PD-L1 CPS≥1.

PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.

ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

Taizhou Hanzhong biomedical co. LTD

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.
HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer	NCT04486651	Stomach Cancer	Irinotecan Hydr... HX008 Placebo	18 Years - 75 Years	Taizhou Hanzhong biomedical co. LTD

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