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.
Female participants aged ≥18 years and ≤75 years at enrollment;
Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma, with histopathological confirmation of high-grade serous carcinoma or endometrioid carcinoma, and FIGO stage (2014 edition) III-IV;
Meeting the neoadjuvant indications for ovarian cancer (preoperative evaluation by a gynecologic oncologist indicates low likelihood of achieving R0 resection with initial debulking surgery, or the patient's physical condition is unsuitable for immediate surgery due to poor tolerance to PDS);
Positive HRD testing result;
Ovarian cancer, fallopian tube cancer, primary peritoneal cancer (e.g., germ cell tumors), or ovarian tumors with low malignant potential (e.g., borderline tumors) of non-epithelial origin;
Previous receipt of antitumor therapy, including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, and immunotherapy (Note: lymph node dissection or biopsy performed for clinical staging purposes using tissue obtained via puncture biopsy or laparoscopic exploration is permitted);
History of other malignancies within the past 5 years, excluding cured localized tumors (e.g., basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ);
Participation in other drug clinical trials and use of investigational drugs within 4 weeks prior to enrollment;
Single group
Sunitinib、Olaparib、Tolilizumab
Drug1. 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.
Total resection rate (R0 resection rate)
All macroscopically visible tumor tissues were surgically removed, and no cancer cells were found at the surgical margins under microscopic examination.
Objective Response Rate (ORR)
refers to the proportion of patients whose tumor volume has decreased by 30% and maintained this reduction for more than four weeks, calculated as the sum of complete response (CR) and partial response (PR).
Disease Control Rate (DCR)
refers to the proportion of all cancer patients receiving a specific treatment who exhibit tumor shrinkage or stabilization, with this condition persisting for a defined period.
Progression-Free Survival (PFS)
refers to the time from randomization until the first occurrence of disease progression or death from any cause.
Pathological Complete Response rate (pCR rate)
absence of infiltrating tumor cells upon microscopic examination after resection of the primary tumor;
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Bai-Rong Xia
Lead sponsor
Anhui Provincial Cancer Hospital
Sponsor institution
Qilu Pharmaceutical Co., Ltd.
Collaborator
