Actively Recruiting
Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer
Led by Anhui Provincial Cancer Hospital · Updated on 2024-11-27
74
Participants Needed
1
Research Sites
179 weeks
Total Duration
On this page
Sponsors
A
Anhui Provincial Cancer Hospital
Lead Sponsor
H
Hutchison Medipharma Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Newly diagnosed with FIGO stage III or IV high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal cancer, or fallopian tube cancer with high-risk recurrence factors
- High-risk recurrence defined as FIGO stage III with non-R0 resection, FIGO stage IV, or presence of ascites at diagnosis
- Have undergone primary debulking surgery for ovarian cancer
- ECOG performance status score of 0 to 2
- Postoperative administration time within 12 weeks
- Expected survival of at least 3 months
- Major organ function within 7 days prior to treatment with hemoglobin ≥90 g/L, absolute neutrophil count ≥1.5×10⁹/L, and platelets ≥100×10⁹/L
- Biochemical parameters meeting specified limits for total bilirubin, ALT, AST, and creatinine or creatinine clearance
- Women of childbearing potential must use effective contraception
- Voluntarily sign informed consent form
- Ability and willingness to comply with study follow-up and procedures
You will not qualify if you...
- Previous treatment with anti-angiogenic drugs such as apatinib, sorafenib, anlotinib, or bevacizumab
- Pregnant or breastfeeding women
- Participation in other ongoing clinical trials
- Significant bleeding events or thromboembolic events within defined recent periods
- Uncontrolled hypertension with systolic ≥150 mmHg or diastolic ≥100 mmHg
- Grade I or higher myocardial ischemia, arrhythmias including QTc ≥480 ms, or NYHA class ≥2 heart failure
- Active or uncontrolled severe infections (≥CTC AE grade 2)
- Renal failure requiring dialysis
- History of immunodeficiency or organ transplantation
- Persistent proteinuria ≥++ confirmed by two urine tests and 24-hour urine protein >1.0 g
- Psychiatric disorders including epilepsy, dementia, severe depression, or mania
- Any bleeding disorder history or recent severe bleeding events
- Arterial or venous thrombotic events within past 6 months
- Symptomatic brain metastases or symptoms controlled less than 2 months
- History of substance abuse or psychiatric disorders
- Difficulty swallowing or known drug absorption disorders
- Allergies to sorafenib or paclitaxel/carboplatin
- Any other condition deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anhui Cancer Hospital
Hefei, Anhui, China, 230001
Actively Recruiting
Research Team
B
Bairong Xia, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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