Spots Global Cancer Trial Database for RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression

Study Description

Brief Summary: 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.

Detailed Description: 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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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