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
1 other identifier
interventional
351
1 country
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 gastric-cancer
Started Mar 2021
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 19, 2021
CompletedStudy Start
First participant enrolled
March 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedDecember 21, 2023
December 1, 2023
3.7 years
January 15, 2021
December 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
within approximately 3 years
Secondary Outcomes (5)
Progression-free survival (PFS), evaluated by the investigator
within approximately 3 years
Objective remission rate (ORR)
within approximately 3 years
Duration of relief (DOR)
within approximately 3 years
Disease control rate (DCR)
within approximately 3 years
Tumor progression time (TTP)
within approximately 3 years
Study Arms (2)
RC48-ADC
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral.
Interventions
2.5 mg/kg IV every 2 weeks
Administered according to label, as one option for Physician's Choice (determined before randomization)
Administered according to label, as one option for Physician's Choice (determined before randomization)
Administered according to label, as one option for Physician's Choice (determined before randomization)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2021
First Posted
January 19, 2021
Study Start
March 24, 2021
Primary Completion
December 1, 2024
Study Completion
June 30, 2025
Last Updated
December 21, 2023
Record last verified: 2023-12