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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
351
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)
Overall survival (OS)
Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
Time frame: within approximately 3 years
Progression-free survival (PFS), evaluated by the investigator
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.
Time frame: within approximately 3 years
Objective remission rate (ORR)
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).
Time frame: within approximately 3 years
Duration of relief (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Time frame: within approximately 3 years
Disease control rate (DCR)
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 frame: within approximately 3 years
Tumor progression time (TTP)
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).
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Administered according to label, as one option for Physician's Choice (determined before randomization)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGAffiliated Hospital of Hebei University
Baoding, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, China
RECRUITINGLuhe Hospital Affiliated to Capital Medical University
Beijing, China
RECRUITINGPeking University People's Hospital
Beijing, China
RECRUITINGJilin Provincial Tumor Hospital
Changchun, China
RECRUITINGXiangya Hospital of Central South University
Changsha, China
RECRUITINGAffiliated Hospital of Chengde Medical College
Chengde, China
RECRUITINGThree Gorges Hospital Affiliated to Chongqing University
Chongqing, China
RECRUITINGFujian Cancer Hospital
Fuzhou, China
RECRUITING...and 42 more locations
Time frame: within approximately 3 years