Safety and Efficacy of RIF Combined With Anlotinib in the Treatment of Patients With Advanced Rec… (NCT07075250) | Clinical Trial Compass
Not Yet RecruitingPhase 4
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
30 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. The patient voluntarily participates in this study and signs the informed consent form.
✓. Female aged 18-70 years.
✓. Histologically confirmed advanced (FIGO stage III/IV) serous or ovarian endometrioid carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma.
✓. Disease recurrence within 6 months after the last platinum-based chemotherapy or progression during chemotherapy (i.e., platinum-resistant or platinum-refractory).
✓. ECOG performance status of 0 or 1, with an expected survival of ≥4 months.
✓. Adequate organ function, meeting the following laboratory criteria within 14 days before enrollment:
✓. Hemoglobin (Hb) ≥80 g/L;
✓. Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
Exclusion criteria
✕. Clinically significant hemoptysis (\>50 mL/day within 3 months before enrollment) or active bleeding (e.g., gastrointestinal hemorrhage, hemorrhagic gastric ulcer, baseline fecal occult blood ≥++), or vasculitis.
What they're measuring
1
PFS(Progression-Free Survival)
Timeframe: Evaluation at 3 months, 6 months, and 12 months of treatment
✕. Arterial/venous thromboembolic events within 6 months (e.g., cerebrovascular accident, deep vein thrombosis \[unless catheter-related and resolved\], pulmonary embolism).
✕. Uncontrolled hypertension (systolic \>140 mmHg or diastolic \>90 mmHg despite medication) or history within 6 months of myocardial infarction, severe/unstable angina, NYHA class ≥2 heart failure, clinically significant arrhythmias, or symptomatic congestive heart failure.
✕. Renal insufficiency: urine protein ≥++ or 24-hour urine protein ≥1.0 g.
✕. Live attenuated vaccination within 28 days before the first dose or planned during the study.
✕. HIV infection or AIDS; active hepatitis (HBV-DNA ≥500 IU/mL; HCV-RNA above detection limit) or coinfection with HBV/HCV.
✕. Severe infection within 4 weeks (e.g., bacteremia, severe pneumonia requiring hospitalization) or active infection (CTCAE ≥grade 2) requiring systemic antibiotics within 2 weeks; unexplained fever \>38.5°C during screening (unless tumor-related per investigator); active tuberculosis within 1 year.