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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Anhui Cancer Hospital
RECRUITING
Hefei
Contact Information
Primary
Bairong Xia, Doctor
xiabairong9999@126.com
18604516165
Time Frame
Start Date: 2024-05-25
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 74
Treatments
Experimental: First-line and maintenance therapy regimen
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.
Related Therapeutic Areas
Sponsors
Collaborators: Hutchison Medipharma Limited
Leads: Anhui Provincial Cancer Hospital

This content was sourced from clinicaltrials.gov