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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
PFS(Progression-Free Survival)
Time frame: Evaluation at 3 months, 6 months, and 12 months of treatment
OS(Overall Survival)
Time frame: Evaluation at 3 months, 6 months, 12 months and 24 month of treatment
ORR(Objective Response Rate)
Time frame: Evaluation at 3 months, 6 months, and 12 months of treatment
DCR((Disease Control Rate))
Time frame: Evaluation at 3 months, 6 months, and 12 months of treatment
QOL(Quality Of Life)
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) is a widely used tool to assess the health-related quality of life (HRQoL) in cancer patients. 1. Global Health Status/Quality of Life ≥70 points: Good quality of life (close to healthy population). 50-69 points: Moderate, with possible minor impact. \<50 points: Poor, requiring clinical intervention. 2. Functional Scales Physical Functioning (PF): Low scores indicate limitations in daily activities. Emotional Functioning (EF): Low scores suggest anxiety/depression risk, warranting psychological intervention. Social Functioning (SF): Low scores reflect negative disease impact on interpersonal relationships. 3. Symptom Scales Fatigue (FA): Scores \>50 indicate a need to evaluate anemia or treatment side effects. Pain (PA): Scores \>40 require initiation of pain management. Nausea/Vomiting (NV): Scores \>30 necessitate antiemetic regimen adjustment.
Time frame: According to the EORTC QLQ-C30 criteria, evaluations were carried out at 3, 6, and 12 months of treatment.
AE(Adverse Event) assessment
Time frame: During the study up to 24 months
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