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

NCT06437353 | Recruiting Phase 2

• 1 other identifier: 2024 No. 047
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ovarian Cancer

Keywords

Antiangiogenic

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression-free survival on first-line and maintenance therapy with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib

  12-month

Secondary Outcomes (4)

• Overall Response Rate (ORR

  3-month

• Disease control rate

  3-month

• Overall survival

  3-years

• Adverse event

  3-month

Study Arms (1)

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.

Drug: Paclitaxel

Interventions

Paclitaxel DRUG

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.

Also known as: Surufatinib, Carboplatin

First-line and maintenance therapy regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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, 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);

You may not qualify 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 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.

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead
• Hutchison Medipharma Limited: collaborator

Study Sites (1)

Anhui Cancer Hospital

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Paclitaxel; surufatinib; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Bairong Xia, Doctor

  Anhui Provincial Cancer Hospital

  STUDY CHAIR

• Wenjing Jiang

  Anhui Provincial Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Bairong Xia, Doctor

CONTACT

18604516165; xiabairong9999@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecological Surgery

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: May 31, 2024
• Study Start: May 25, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2027
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)