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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

NCT07075250 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-20

No results posted yet for this study

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.

Conditions

  • Platinum-resistant Ovarian Cancer (PROC)

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.

Sponsors & Collaborators

  • Beijing Friendship Hospital

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Tianjin People's Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Shanxi Medical University

    collaborator OTHER

  • Tianchang Yifan Pharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Peking University People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-12-31
Completion
2029-12-31

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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 NCT07075250 on ClinicalTrials.gov