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NOT YET RECRUITING
NCT07075250
PHASE4

Safety and Efficacy of RIF Combined With Anlotinib in the Treatment of Patients With Advanced Recurrent Platinum-Resistant Ovarian Cancer: A Prospective, Multicenter Clinical Study

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

This project plans to conduct a prospective, multicenter clinical study. The intended participants are patients with histologically confirmed advanced (FIGO III/IV stage) ovarian serous carcinoma, ovarian endometrioid carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma who have platinum-resistant recurrence or are platinum-refractory (n=30). The study design is a single-arm study. The treatment regimen for the study group is the RIF combined with anlotinib group, with continuous administration until disease progression, death, intolerable toxicity, loss to follow-up, withdrawal of informed consent, or study termination, whichever occurs first. The treatment duration will not exceed 18 months, with a follow-up period of 24 months. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life score (QOL), and safety. The primary efficacy evaluation will use imaging methods (RECIST 1.1) combined with tumor marker CA125 levels. All data in this study will be summarized using appropriate statistical measures based on data type: continuous data will be described using mean, standard deviation (STD), median, minimum, and maximum, while categorical data will be summarized using frequency and percentage (proportion). Time-to-event data will be analyzed using the Kaplan-Meier (KM) product-limit method to estimate median survival time, with survival curves plotted and 95% confidence intervals for median time estimated when necessary. This study aims to evaluate the efficacy and safety of RIF combined with anlotinib in patients with platinum-resistant recurrent ovarian cancer, providing a new therapeutic strategy.

Official title: Safety and Efficacy of Realgar-Indigo Naturalis Formula(RIF) Combined With Anlotinib in the Treatment of Patients With Advanced Recurrent Platinum-Resistant Ovarian Cancer: A Prospective, Multicenter Clinical Study

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-09-01

Completion Date

2029-12-31

Last Updated

2025-07-20

Healthy Volunteers

No

Interventions

DRUG

Realgar-Indigo Naturalis Formulation Combined with Anlotinib

RIF: Oral administration after meals, 6 tablets each time, three times daily (tid), from day 1 to day 14 (d1-14), every 3 weeks (q3w), continuous dosing. Anlotinib : Oral administration before breakfast, 10 mg each time, once daily (qd), from day 1 to day 14 (d1-14), every 3 weeks (q3w), continuous dosing. Subjects will continue the study treatment until meeting the protocol-defined discontinuation criteria. The total treatment duration should not exceed 18 months.