NCT06437353招募中2 期
Sorafenib Combined With Carboplatin/Paclitaxel and Sorafenib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer: a Single-arm, Multicenter, Exploratory Clinical Study
Anhui Provincial Cancer Hospital1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年5月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The goal of this type of clinical trial study is to evaluate the safety and efficacy of Surufatinib combined with Carboplatin/Paclitaxel and Surufatinib combined with Olaparib as first-line and maintenance therapy for newly diagnosed high-risk ovarian cancer
详细描述
Patients will have tests and exams to see if they are eligible for the clinical trial.
First-line chemotherapy regimen:
Paclitaxel/Carboplatin(repeat every 3 weeks, total of 6 cycles):
- Paclitaxel: 175 mg/m², intravenous infusion, on day 1.
- Carboplatin: AUC 5, intravenous infusion, on day 1.
- For patients aged ≥70 years or those with comorbidities, the paclitaxel dose can be adjusted to 135 mg/m².
Surufatinib(repeat every 3 weeks, total of 5 cycles):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old (≥18, ≤75)
- •Patients with newly diagnosed FIGO stage III or IV high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal cancer, and/or fallopian tube cancer with high-risk factors for recurrence. High-risk recurrence is defined as follows:
- •FIGO stage III with non-R0 resection;
- •FIGO stage IV;
- •Presence of ascites at initial diagnosis.
- •Patients who have undergone primary debulking surgery (PDS) for ovarian cancer.
- •ECOG performance status score: 0-
- •Postoperative administration time ≤12 weeks.
- •Expected survival of at least 3 months.
- •Major organ function within 7 days prior to treatment meets the following criteria:
- •Hemoglobin (HB) ≥90 g/L;
- •Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
- •Platelets (PLT) ≥100×10⁹/L.
- •Biochemical parameters must meet the following standards:
- •Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, or ≤5×ULN if liver metastases are present;
- •Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60 ml/min.
- •Women of childbearing potential must use effective contraception.
- •Subjects must voluntarily join the study and sign the informed consent form (ICF).
- •Subjects are expected to have good compliance and the ability to follow up on efficacy and adverse reactions as required by the protocol.
排除标准
- •Previous treatment with anti-angiogenic drugs such as apatinib, sorafenib, anlotinib, bevacizumab, or other anti-angiogenic therapies.
- •Pregnant or breastfeeding women.
- •Patients who have previously participated in other clinical trials that have not yet concluded.
- •Patients with evidence or history of significant bleeding tendencies or events within 3 months before enrollment (bleeding >30 mL, accompanied by hematemesis, melena, or hematochezia), hemoptysis (≥5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months.
- •Patients with uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
- •Patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc ≥480 ms), or ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification).
- •Patients with active or uncontrolled severe infections (≥CTC AE grade 2).
- •Patients with renal failure requiring hemodialysis or peritoneal dialysis.
- •Patients with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation.
- •Patients with persistent proteinuria (≥++) on two consecutive urine tests, and confirmed 24-hour urine protein >1.0 g.
- •Patients with psychiatric disorders, including epilepsy, dementia, severe depression, mania, etc.
- •Patients with any signs or history of bleeding disorders, regardless of severity; patients who experienced any bleeding or hemorrhagic event ≥CTCAE grade 3 within 4 weeks before enrollment; patients with unhealed wounds, ulcers, or fractures.
- •Patients who had arterial or venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, within the past 6 months.
- •Patients with symptomatic brain metastases or those whose symptoms have been controlled for less than 2 months.
- •Patients with a history of substance abuse that cannot be relinquished or those with psychiatric disorders.
- •Patients with difficulty swallowing or known absorption disorders affecting drug intake.
- •Patients allergic to treatment drugs sorafenib or paclitaxel/carboplatin.
- •Any other condition that the researcher deems unsuitable for enrollment.
研究组 & 干预措施
First-line and maintenance therapy regimen
Experimental
First-line chemotherapy regimen:
- Paclitaxel: 175 mg/m², intravenous infusion, on day 1.
- Carboplatin: AUC 5, intravenous infusion, on day 1.
- Surufatinib：250 mg once daily, taken continuously.
Maintenance Therapy Regimen:
- Surufatinib: 250 mg once daily, taken continuously.
- Olaparib: 300 mg twice daily.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression free survival
时间窗: 12-month
Progression-free survival on first-line and maintenance therapy with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib
次要结局
- Overall Response Rate (ORR(3-month)
- Disease control rate(3-month)
- Overall survival(3-years)
- Adverse event(3-month)
研究者
Bai-Rong Xia
Director of Gynecological Surgery
Anhui Provincial Cancer Hospital
研究点 (1)
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