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This study will evaluate the efficacy and safety of intravenous RC48-ADC in local advanced or metastatic gastric patients with the overexpression of HER2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC48-ADC | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC48-ADC | Drug | 2.5 mg/kg IV every 2 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) as Assessed by investigator | Tumor response was assessed by investigator according to RECIST v1.1 | up to 24 months |
| Overall Survival(OS) | OS was defined as the time from the first study treatment to the date of death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34665942 | Derived | Peng Z, Liu T, Wei J, Wang A, He Y, Yang L, Zhang X, Fan N, Luo S, Li Z, Gu K, Lu J, Xu J, Fan Q, Xu R, Zhang L, Li E, Sun Y, Yu G, Bai C, Liu Y, Zeng J, Ying J, Liang X, Xu N, Gao C, Shu Y, Ma D, Dai G, Li S, Deng T, Cui Y, Fang J, Ba Y, Shen L. Efficacy and safety of a novel anti-HER2 therapeutic antibody RC48 in patients with HER2-overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single-arm phase II study. Cancer Commun (Lond). 2021 Nov;41(11):1173-1182. doi: 10.1002/cac2.12214. Epub 2021 Oct 19. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| up to 24 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |