A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression
- Conditions
- Gastric CancerHER2 Overexpressing Gastric Carcinoma
- Interventions
- Registration Number
- NCT04714190
- Lead Sponsor
- RemeGen Co., Ltd.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 351
- 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.
- Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physician's Choice Irinotecan Hydrochloride Injection Participants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral. Physician's Choice Apatinib Mesylate Tablets Participants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral. RC48-ADC 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). Physician's Choice Paclitaxel injection Participants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral.
- Primary Outcome Measures
Name Time Method Overall survival (OS) within approximately 3 years Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS), evaluated by the investigator within approximately 3 years 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.
Objective remission rate (ORR) within approximately 3 years 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).
Duration of relief (DOR) within approximately 3 years 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) within approximately 3 years 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.
Tumor progression time (TTP) within approximately 3 years 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).
Trial Locations
- Locations (52)
Jilin Provincial Tumor Hospital
🇨🇳Changchun, China
The Sixth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Anhui Cancer Hospital
🇨🇳Hefei, China
Jinan Central Hospital
🇨🇳Jinan, China
Affiliated Hospital of Jining Medical College
🇨🇳Jining, China
China-Japan Friendship Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, China
Linyi Tumor Hospital
🇨🇳Linyi, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Zhongshan Hospital Affiliated to Fudan University
🇨🇳Shanghai, China
Cancer Hospital Affiliated to Shantou University Medical College
🇨🇳Shantou, China
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
🇨🇳Nanjing, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, China
Huazhong University of Science Tongji Hospital, Tongji Medical College
🇨🇳Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, China
Xuzhou Central Hospital
🇨🇳Xuzhou, China
Weifang People's Hospital
🇨🇳Weifang, China
Subei People's Hospital of Jiangsu Province
🇨🇳Yangzhou, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Affiliated Hospital of Chengde Medical College
🇨🇳Chengde, China
Luhe Hospital Affiliated to Capital Medical University
🇨🇳Beijing, China
The Affiliated Tumor Hospital of Harbin Medical University
🇨🇳Harbin, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, China
Xiangya Hospital of Central South University
🇨🇳Changsha, China
Three Gorges Hospital Affiliated to Chongqing University
🇨🇳Chongqing, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, China
Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Anhui Provincial Hospital
🇨🇳Hefei, China
The First People's Hospital of Jining City
🇨🇳Jining, China
Shandong Cancer Hospital
🇨🇳Jinan, China
Qingdao University Hospital
🇨🇳Qingdao, China
Shanghai Changhai Hospital
🇨🇳Shanghai, China
Liaoning Cancer Hospital
🇨🇳Shenyang, China
Shenzhen People's Hospital
🇨🇳Shenzhen, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Tianjin Cancer Hospital
🇨🇳Tianjin, China
Weihai Municipal Hospital
🇨🇳Weihai, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, China
Qinghai Provincial People's Hospital
🇨🇳Xining, China
The First Affiliated Hospital of Xinxiang Medical College
🇨🇳Xinxiang, China
Southern Hospital of Southern Medical University
🇨🇳Guangzhou, China
First Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Drum Tower Hospital Affiliated to Nanjing University School of Medicine
🇨🇳Nanjing, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
Affiliated Hospital of Qinghai University
🇨🇳Xining, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China