RecruitingPhase 2NCT07667751

An Exploratory Study on the Use of Ipalotinib (Tislelizumab) Combined With Sunitinib and Olaparib for Neoadjuvant Therapy in HRD-positive Advanced Ovarian Cancer

Sponsor

Bai-Rong Xia

Enrollment

35 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Ovary Cancer

Summary

The R0 resection rate in neoadjuvant chemotherapy for advanced ovarian cancer remains below 50%, indicating unmet clinical needs. Tyrosine kinase inhibitors (TKIs) can induce immune microenvironment remodeling and exhibit synergistic effects with immune checkpoint inhibitors. To further evaluate the efficacy and safety of epalolide combined with torvolumab plus sunitinib and olaparib as neoadjuvant therapy in HRD-positive untreated patients with advanced ovarian cancer, a prospective, multicenter, single-arm exploratory study is proposed. This study will enroll 35 untreated HRD-positive advanced ovarian cancer patients who will receive neoadjuvant treatment with epalolide plus torvolumab combined with sunitinib and olaparib. Patients achieving CR/PR/SD after neoadjuvant therapy will undergo intermediate tumor cytoreductive surgery, followed by 6 cycles of adjuvant chemotherapy and 1 year of maintenance therapy with the etoricoxib-drug combination antibody regimen. The primary endpoint is R0 resection rate, aiming to provide valuable insights into neoadjuvant treatment strategies for advanced ovarian cancer patients.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Sunitinib、Olaparib、Tolilizumab for people with ovary cancer. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSunitinib、Olaparib、Tolilizumab

1. Preoperative neoadjuvant therapy: Sunitinib: 37.5 mg, qd, orally; discontinuation required for at least 4 weeks prior to surgery; Olaparib: 300 mg, bid, every 3 weeks × 3 cycles; Epalolide and Torvori-mab: infusion of sunitinib and olaparib begins on day 22 of treatment, 5 mg/kg intravenous, every 3 weeks × 2 cycles. 2. Patients who achieve CR/PR/SD after neoadjuvant therapy shall undergo intermediate tumor cytoreductive surgery; those assessed as PD-positive shall receive treatment for recurrent/metastatic ovarian cancer. 3. Postoperative adjuvant therapy: 6 cycles of chemotherapy; maintenance therapy with etoposide combination antibody plus olaparib ± sunitinib, with etoposide combination antibody maintenance therapy lasting 1 year.