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

NCT05736952 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Oral Topotecan Combined With Anlotinib

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.

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Xipeng Wang, Dr · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05736952 on ClinicalTrials.gov