Efficacy and Safety of Low-Dose Lenvatinib and Toripalimab in Patients With Recurrent Platinum-Resistant Ovarian Cancer: Study Protocol of a Multicenter, Open-Label, Single-Arm, Phase II Clinical Trial

The study is designed as a multicenter, open-label, single-arm, prospective phase II study. Patients with recurrent epithelial ovarian cancer who have disease progression either during or within 6 months after completion of platinum-based therapy will be included. A total of 69 participants will receive low-dose lenvatinib (8 mg or 12 mg, daily, orally, based on patient's body weight) and toripalimab (240 mg, every 21 days, intravenously). Treatment will continue until the development of unacceptable toxicity or disease progression. The primary endpoint is the progression-free survival. The secondary endpoints include objective response rate, duration of response, disease control rate, overall survival, toxicity and patients' quality of life. Exploratory objectives aim to identify biomarkers and molecular signatures for predicting response or prognosis.