Study of Disitamab Vedotin Combined with Anlotinib Hydrochloride for HER-2 Positive Recurrent Platinum-Resistant Ovarian Cancer

What this Trial Is About

Ovarian cancer is a serious disease affecting the female reproductive system, with many patients experiencing recurrence despite surgery and chemotherapy. This trial focuses on patients with recurrent platinum-resistant ovarian cancer PROC, a group with poor prognosis and limited treatment options. Researchers are studying a combination of two drugs, Disitamab Vedotin RC48, a HER2-targeted antibody drug, and Anlotinib, an oral anti-angiogenic agent, to explore their safety and effectiveness in treating this condition. Participants will receive Disitamab Vedotin intravenously at a dose of 2.0 mgkg every two weeks, along with Anlotinib capsules taken orally at 10 mg daily for two weeks followed by a one-week break, repeating every 21 days. This combination therapy aims to improve response rates and quality of life by targeting HER2-expressing tumors with different mechanisms and manageable side effects. Throughout the study, participants will undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, survival tracking, and monitoring of side effects for up to two years. Researchers will evaluate objective response rate ORR as the primary outcome, along with progression-free survival, overall survival, disease control rate, and duration of response. This careful monitoring will help understand the treatments impact on tumor control and patient well-being.

Exploratory Study on the Safety and Efficacy of Disitamab Vedotin in Combination with Anlotinib Hydrochloride for the Treatment of HER-2-expressing Recurrent Platinum-resistant Ovarian Cancer.