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| Name | Class |
|---|---|
| Beijing Friendship Hospital | OTHER |
| Peking University First Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIF Combined with Anlotinib | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Realgar-Indigo Naturalis Formulation Combined with Anlotinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS(Progression-Free Survival) | Evaluation at 3 months, 6 months, and 12 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| OS(Overall Survival) | Evaluation at 3 months, 6 months, 12 months and 24 month of treatment | |
| ORR(Objective Response Rate) | Evaluation at 3 months, 6 months, and 12 months of treatment | |
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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:
**Complete blood count (without transfusion within 14 days):**
**Biochemical tests:**
**Cardiac function:** Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
Ability to take oral medications.
≥4 weeks since the last chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other antitumor treatments before the first dose of study drugs.
Women of childbearing potential must agree to use highly effective contraception during the study and for 6 months after the last dose. A negative serum or urine pregnancy test within 7 days before enrollment is required, and the patient must be non-lactating.
Exclusion Criteria:
1. Prior treatment with arsenic agents (e.g., arsenic trioxide, Compound Huangdai Tablets) or anlotinib hydrochloride/other targeted therapies.
2. Known hypersensitivity to anlotinib or its excipients. 3. Known hypersensitivity to arsenic agents or their excipients. 4. **Comorbidities/medical history:**
5. Current/recent (within 30 days) use of another investigational drug or participation in another clinical trial.
6. Conditions severely affecting oral drug absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
7. Any condition that may interfere with study results or compliance, per investigator judgment.
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| OTHER |
| Tianjin People's Hospital | OTHER |
| The First Affiliated Hospital of Shanxi Medical University | OTHER |
| Tianchang Yifan Pharmaceutical Co., Ltd. | UNKNOWN |
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| DCR((Disease Control Rate)) |
| 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.
Pain (PA): Scores >40 require initiation of pain management. Nausea/Vomiting (NV): Scores >30 necessitate antiemetic regimen adjustment. | According to the EORTC QLQ-C30 criteria, evaluations were carried out at 3, 6, and 12 months of treatment. |
| AE(Adverse Event) assessment | During the study up to 24 months |
| ID | Term |
|---|---|
| C000625192 | anlotinib |
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