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

NCT07667751 | Recruiting Phase 2 DMC

• 1 other identifier: 2025-LLYJ-0153
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovary Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  3-month

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  12-month

• Disease Control Rate (DCR)

  12-month

• Progression-Free Survival (PFS)

  12-month

• Pathological Complete Response rate (pCR rate)

  12-month

• Overall Survival (OS)

  12-month

Study Arms (1)

Study Medication Regimen

EXPERIMENTAL

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.

Drug: Sunitinib、Olaparib、Tolilizumab

Interventions

Sunitinib、Olaparib、Tolilizumab DRUG

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.

Study Medication 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:

• 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;
• Presence of at least one measurable lesion meeting RECIST 1.1 criteria;
• Expected survival time ≥12 weeks;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Absence of severe hematologic, cardiac, pulmonary, hepatic, renal dysfunction, or immunodeficiency disorders. Within one week prior to the first administration, the functional status of vital organs must meet the following requirements (supportive therapies such as any blood components or cell growth factors are prohibited within 14 days before the first dose):
• Complete blood count: HGB ≥ 90 g/L; WBC ≥ 4.0 × 10⁹/L; NEUT ≥ 2.0 × 10⁹/L; PLT ≥ 100 × 10⁹/L;
• Blood biochemistry: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; BUN and Cr ≤ 1.5 × ULN with creatinine clearance ≥ 50 mL/min;
• Coagulation function: INR ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN;
• Within 4 weeks prior to the first dose, cardiac ultrasound must demonstrate: left ventricular ejection fraction (LVEF)\> 50%;
• Pregnancy test results must be negative in patients of childbearing age, with voluntary use of effective and reliable contraceptive measures during the study;
• Participants must voluntarily enroll in the study, sign an informed consent form, demonstrate good compliance, and agree to participate in follow-up visits.

You may not qualify if:

• 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;
• Administration of live attenuated vaccines within 4 weeks before initial dosing or planned during the study period;
• Known history of allergy to any component of this regimen;
• Subjects with active infectious diseases;
• Subjects with any severe and/or uncontrolled diseases;
• Active autoimmune diseases requiring systemic treatment within 2 years prior to study initiation, or autoimmune diseases at risk of recurrence; exceptions include: non-systemically treatable dermatoses (e.g., vitiligo, alopecia, psoriasis, or eczema); hypothyroidism due to autoimmune thyroiditis requiring only stable hormone replacement therapy; well-controlled type 1 diabetes mellitus; and conditions deemed by investigators unlikely to recur without external triggers;
• Pregnant or breastfeeding women, or women of childbearing potential with positive baseline pregnancy test results.
• According to the investigator's assessment, the patient has a severe comorbid condition that poses significant risks to safety or impedes participation in the study, including but not limited to: severe hypertension uncontrolled by medication (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg), myocardial ischemia or myocardial infarction, severe arrhythmias, congestive heart failure grade ≥2, severe pulmonary dysfunction/disease, severe diabetes mellitus, or active infections;
• A documented history of neurological or psychiatric disorders, including epilepsy or dementia;
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Known history of interstitial lung disease or non-infectious pneumonia;
• Diagnosis of immunodeficiency or ongoing systemic glucocorticoid therapy or any other form of immunosuppressive treatment;

Sponsors & Collaborators

• Bai-Rong Xia: lead
• Qilu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Anhui Cancer Hospital

Hefei, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

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

Central Study Contacts

Bai-Rong Xia, MD

CONTACT

18604516165; xiabairong9999@126.com

Yao Chen

CONTACT

cyao49446@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice dean

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

CN (1)