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The purpose of this study is to evaluate the efficacy, safety, and quality of life scores of patients with HER2-expressing platinum-sensitive recurrent epithelial ovarian cancer treated with the combination therapy regimen of RC48 plus platinum with or without bevacizumab.
This study set up a safety introduction period, during which the first 6 subjects who were initially enrolled in the study will slowly undergo safety monitoring. Each patient received RC48 [2.5 mg/kg, Q3W]+carboplatin (AUC5 d1 q3w) ± bevacizumab(7.5-15mg/kg d1 q3w) treatment. The monitoring time window is within 28 days after receiving the study drug treatment for the first time. If ≥ 2 dose limited toxicity (DLT) cases were observed in the first 6 subjects, and after evaluation by the research team, it was found that the toxicity was related to treatment with RC48, the initial dose of RC48 treatment for subsequent enrolled patients was adjusted to 2.0mg/kg, Q3W.
Treatment period: RC48+carboplatin ± bevacizumab, repeated every three weeks for a total of 6 cycles; Maintenance period: RC48± bevacizumab (if combined with bevacizumab during the treatment period, maintain treatment with RC48 in combination with bevacizumab; if not used during the treatment period, maintain treatment with RC48 monotherapy). Maintenance duration: Until disease progression or intolerable toxicity occurs, the longest duration of RC48 is 6 months (8 cycles).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC48+carboplatin±bevacizumab | Experimental | RC48 (2.5mg/kg iv on d1 , every 21d for 6 cycles) + Carboplatin (AUC5 iv on d1 every 21d for 6 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for 6 cycles) for treatment followed by RC48 (2.5mg/kg iv on d1 , every 21d for 8 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for progress ) maintenance therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC48+carboplatin±bevacizumab | Drug | RC48 (2.5mg/kg iv on d1 , every 21d for 6 cycles) + Carboplatin (AUC5 iv on d1 every 21d for 6 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for 6 cycles) for treatment followed by RC48 (2.5mg/kg iv on d1 , every 21d for 8 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for progress ) maintenance therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as time (in months) from date of randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause in the absence of documented PD (whichever occurs first). PFS will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator response assessment. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | ORR is defined as Investigator-assessed CR + PR, per RECIST 1.1 | Up to approximately 2 years |
| Disease Control Rate (DCR) | DCR is defined as the percentage of cases with remission (PR+CR) and stable disease (SD) after treatment in the evaluable cases. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Zheng, M.D. | Contact | 86-010-88196100 | zhhong306@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Zheng | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Up to approximately 2 years |
| Overall Survival(OS) | OS is defined as the time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death. | Up to approximately 2 years |
| Number of Participants With Adverse Events (AEs) | Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0). | Up to approximately 2 years |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |