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.
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).
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.
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.
Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., pulmonary fibrosis, acute pneumonia).
Single group
Realgar-Indigo Naturalis Formulation Combined with Anlotinib
DrugRIF: 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)
OS(Overall Survival)
ORR(Objective Response Rate)
DCR((Disease Control Rate))
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.
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Peking University People's Hospital
Lead sponsor
Beijing Friendship Hospital
Collaborator
Peking University First Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Tianjin People's Hospital
Collaborator
The First Affiliated Hospital of Shanxi Medical University
Collaborator
Tianchang Yifan Pharmaceutical Co., Ltd.
Collaborator
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