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New treatment option for Ovarian Cancer
Official title Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer
ClinicalTrials.gov ID: NCT06437353
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ovarian cancer.
Also referred to as Surufatinib, Carboplatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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...
- FIGO stage III with non-R0 resection;
- FIGO stage IV;
- Presence of ascites at initial diagnosis.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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.
- people must voluntarily join the study and sign the informed consent form (ICF).
- people are expected to have good compliance and the ability to follow up on how well it works and adverse reactions as required by the protocol.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.