Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer

Официальное название

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

Обзор

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

Подробное описание

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):

* Surufatinib is not used during the first postoperative cycle. * Starting from the second postoperative cycle, surufatinib is administered at a dose of 250 mg once daily, taken continuously.

Maintenance Therapy Regimen:

HRD-positive Patients:

* Surufatinib: 250 mg once daily, taken continuously. * Olaparib: 300 mg twice daily, with doses taken 12 hours apart. Olaparib can be used for a maximum of 2 years.

HRD-negative or HRD Status Unknown Patients:

* Surufatinib: 250 mg once daily, taken continuously.

Treatment continues until the patient experiences disease progression or meets other criteria for discontinuation of the study treatment as specified in the protocol.

Вмешательства

• Препарат Paclitaxel
  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.

Первичные конечные точки

• Progression free survival [Срок оценки: 12-month]

Вторичные конечные точки (4)

• Overall Response Rate (ORR [Срок оценки: 3-month]
• Disease control rate [Срок оценки: 3-month]
• Overall survival [Срок оценки: 3-years]
• Adverse event [Срок оценки: 3-month]

Критерии участия

Критерии включения

• 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: 0-2.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Anhui Cancer Hospital — Хэфэй

Идентификаторы

NCT: NCT06437353 · 2024 No. 047

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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