drugset / Trial / NCT05736952

Oral Topotecan Combined With Anlotinib in Patients With Platinum-resistant Recurrent Ovarian Cancer

NCT05736952

NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to evaluate the treatment of topotecan hydrochloride capsules combined with anlotinib hydrochloride capsules in Patients with platinum-resistant recurrent epithelial ovarian cancer. The main questions it aims to answer are: to assess the objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS) and safety of topotecan hydrochloride capsules combined with anlotinib hydrochloride capsules in patients with platinum-resistant recurrent epithelial ovarian cancer.The treatment of participants: Topotecan hydrochloride capsules: 2 mg, once daily, oral with dinner for 5 days, discontinued for 16 days, that is, 21 days (3 weeks) as a course of treatment, a total of 6 courses of administration.;Anlotinib hydrochloride capsules: 10mg once a day, oral before breakfast, continuous administration for 14 days, discontinuation for 7 days, that is, 21 days (3 weeks) as a course of treatment. Receiving optimal supportive care at the same time until disease progression/death/intolerable toxicity.

Timeline

Start
2023-03-01
Primary completion
2026-02-01
Completion
2026-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule 10 mg Oral
Subject Topotecan Small molecule 2 mg Oral