Ovary CancerPhase 2NCT07667751
An Exploratory Study on the Use of Ipalotinib (Tislelizumab) Combined With Sunitinib and Olaparib for Neoadjuvant Therapy in HRD-positive Advanced Ovarian Cancer
A Phase 2 study testing Sunitinib、Olaparib、Tolilizumab in people with Ovary Cancer, run by Bai-Rong Xia at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovary Cancer
- What is being tested?
- Sunitinib、Olaparib、Tolilizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Presence of any condition increasing bleeding risk, such as severe hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
- History of dysphagia or any gastrointestinal disorder affecting drug absorption;
- Any other circumstances deemed inappropriate for study participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yao Chen contact
About this study
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.
Read the detailed description
For patients with advanced ovarian cancer, tumor debulking surgery is a crucial component of treatment. However, due to poor prognosis and high recurrence rates in advanced cases, treatment poses significant challenges. The primary principle of surgical management for advanced ovarian cancer is to achieve maximal tumor resection. The core objective of surgery is to remove all macroscopically visible tumor tissue to minimize postoperative residual disease. Nevertheless, given the complexity of advanced ovarian cancer and individual patient variability, not all patients are suitable candidates for initial tumor debulking surgery. Neoadjuvant chemotherapy combined with intermediate tumor debulking surgery serves as a therapeutic option for patients who cannot achieve satisfactory tumor reduction or are unable to tolerate surgery, and this approach is currently widely employed in clinical practice.
The traditional neoadjuvant treatment regimen for ovarian cancer involves the platinum-paclitaxel dual-drug combination. However, the complete resection rate with pure neoadjuvant chemotherapy remains below 50%, and approximately half of patients fail to achieve complete tumor removal. These patients face the risk of residual tumors postoperatively, which increases the likelihood of disease recurrence, highlighting a significant unmet clinical need. Improving neoadjuvant treatment strategies for ovarian cancer has become a current research focus. Existing studies demonstrate that combining immune checkpoint inhibitors with neoadjuvant chemotherapy can enhance the pathological complete response (pCR) rate in advanced ovarian cancer patients and induce durable clinical responses, suggesting this approach as a promising therapeutic option; however, further validation is required, and the optimal immunotherapy combination strategy requires further exploration.
Apatinib-tolilimumab (hereinafter referred to as the Ato combination antibody) is the world's first dual-functional combination antibody targeting both PD-1 and CTLA-4, capable of simultaneously inhibiting PD-1-and CTLA-4-mediated signaling pathways to exert synergistic antitumor effects with excellent tolerability. In Phase I clinical studies, the Ato combination antibody demonstrated superior safety and tolerability. Among 518 patients with advanced cancer who had failed conventional treatments, only 8.1% experienced grade 3 or higher immune-related adverse events, highlighting its significant safety advantages. In patients with recurrent or metastatic cervical cancer, the pivotal Phase II registration study of the Ato combination antibody achieved remarkable results: an overall response rate (ORR) of 33.8% in second-line systemic therapy and a median progression-free survival (PFS) of 5.4 months. Based on these data, the Ato combination antibody was approved for marketing in China on September 30,2024, indicated for the treatment of recurrent or metastatic cervical cancer patients who had previously failed platinum-based chemotherapy.
PARP inhibitors and antiangiogenic agents can disrupt tumor growth through distinct mechanisms, with their synergistic effects mutually enhancing each other to achieve a 1+1>2 outcome. Multitarget tyrosine kinase inhibitors (TKIs) can induce remodeling of the immune microenvironment and activate the tumor immune response, not only significantly increasing T-cell infiltration into tumors but also upregulating the expression of the immune checkpoint CTLA-4, ultimately enabling tumor cells to evade T-cell attack through immune evasion. CTLA-4 blockade enhances T-cell antitumor activity and effectively reverses the inhibitory immune microenvironment. Sunitinib is a TKI currently used as standard therapy for clear cell renal cell carcinoma (ccRCC) and gastrointestinal stromal tumors (GIST). Studies suggest that sunitinib may play a role in tumor immune monitoring and participate in PD-L1 regulation.
In patients with previously untreated advanced ovarian cancer, the use of neoadjuvant therapy combining TKIs and PARP inhibitors with epalolide and torvocizumab has a solid scientific basis and warrants further investigation. This study innovatively employed sunitinib combined with olaparib for one cycle to induce an immune microenvironment, followed by addition of an immune checkpoint inhibitor, demonstrating synergistic effects. To further evaluate the efficacy and safety of sunitinib and olaparib combined with epalolide and torvocizumab in neoadjuvant treatment for these patients, a prospective, multicenter, single-arm exploratory study is planned to provide valuable insights for developing neoadjuvant treatment regimens for advanced ovarian cancer.
- Conditions
- Ovary Cancer
- Being tested
- Sunitinib、Olaparib、Tolilizumab
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib、Olaparib、TolilizumabDrug
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sunitinib、Olaparib、Tolilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-month
Secondary outcomes (6)
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).
Measured: 12-month
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.
Measured: 12-month
Progression-Free Survival (PFS)
refers to the time from randomization until the first occurrence of disease progression or death from any cause.
Measured: 12-month
Pathological Complete Response rate (pCR rate)
absence of infiltrating tumor cells upon microscopic examination after resection of the primary tumor;
Measured: 12-month
Overall Survival (OS)
refers to the time from randomization until death from any cause.
Measured: 12-month
Adverse Events (AEs)
Collect all adverse events occurring in all subjects from the date of signing the informed consent form until 28 days after discontinuation of medication, including clinical symptoms and abnormalities in vital signs or laboratory tests. Record their clinical manifestations, severity, occurrence time, duration, management measures, and prognosis, and assess their correlation with the investigational drug.
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bai-Rong Xia
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Bai-Rong Xia, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667751
- Sponsor's protocol ID
- 2025-LLYJ-0153
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Use of Ipalotinib (Tislelizumab) Combined With Sunitinib and Olaparib for Neoadjuvant Therapy in HRD-positive Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07667751
- Acronym / sponsor ID
- 2025-LLYJ-0153
- Conditions
- Ovary Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Bai-Rong XiaUniversity, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For patients with advanced ovarian cancer, tumor debulking surgery is a crucial component of treatment. However, due to poor prognosis and high recurrence rates in advanced cases, treatment poses significant challenges. The primary principle of surgical management for advanced ovarian cancer is to achieve maximal tumor resection. The core objective of surgery is to remove all macroscopically visible tumor tissue to minimize postoperative residual disease. Nevertheless, given the complexity of advanced ovarian cancer and individual patient variability, not all patients are suitable candidates for initial tumor debulking surgery. Neoadjuvant chemotherapy combined with intermediate tumor debulking surgery serves as a therapeutic option for patients who cannot achieve satisfactory tumor reduction or are unable to tolerate surgery, and this approach is currently widely employed in clinical practice.
The traditional neoadjuvant treatment regimen for ovarian cancer involves the platinum-paclitaxel dual-drug combination. However, the complete resection rate with pure neoadjuvant chemotherapy remains below 50%, and approximately half of patients fail to achieve complete tumor removal. These patients face the risk of residual tumors postoperatively, which increases the likelihood of disease recurrence, highlighting a significant unmet clinical need. Improving neoadjuvant treatment strategies for ovarian cancer has become a current research focus. Existing studies demonstrate that combining immune checkpoint inhibitors with neoadjuvant chemotherapy can enhance the pathological complete response (pCR) rate in advanced ovarian cancer patients and induce durable clinical responses, suggesting this approach as a promising therapeutic option; however, further validation is required, and the optimal immunotherapy combination strategy requires further exploration.
Apatinib-tolilimumab (hereinafter referred to as the Ato combination antibody) is the world's first dual-functional combination antibody targeting both PD-1 and CTLA-4, capable of simultaneously inhibiting PD-1-and CTLA-4-mediated signaling pathways to exert synergistic antitumor effects with excellent tolerability. In Phase I clinical studies, the Ato combination antibody demonstrated superior safety and tolerability. Among 518 patients with advanced cancer who had failed conventional treatments, only 8.1% experienced grade 3 or higher immune-related adverse events, highlighting its significant safety advantages. In patients with recurrent or metastatic cervical cancer, the pivotal Phase II registration study of the Ato combination antibody achieved remarkable results: an overall response rate (ORR) of 33.8% in second-line systemic therapy and a median progression-free survival (PFS) of 5.4 months. Based on these data, the Ato combination antibody was approved for marketing in China on September 30,2024, indicated for the treatment of recurrent or metastatic cervical cancer patients who had previously failed platinum-based chemotherapy.
PARP inhibitors and antiangiogenic agents can disrupt tumor growth through distinct mechanisms, with their synergistic effects mutually enhancing each other to achieve a 1+1>2 outcome. Multitarget tyrosine kinase inhibitors (TKIs) can induce remodeling of the immune microenvironment and activate the tumor immune response, not only significantly increasing T-cell infiltration into tumors but also upregulating the expression of the immune checkpoint CTLA-4, ultimately enabling tumor cells to evade T-cell attack through immune evasion. CTLA-4 blockade enhances T-cell antitumor activity and effectively reverses the inhibitory immune microenvironment. Sunitinib is a TKI currently used as standard therapy for clear cell renal cell carcinoma (ccRCC) and gastrointestinal stromal tumors (GIST). Studies suggest that sunitinib may play a role in tumor immune monitoring and participate in PD-L1 regulation.
In patients with previously untreated advanced ovarian cancer, the use of neoadjuvant therapy combining TKIs and PARP inhibitors with epalolide and torvocizumab has a solid scientific basis and warrants further investigation. This study innovatively employed sunitinib combined with olaparib for one cycle to induce an immune microenvironment, followed by addition of an immune checkpoint inhibitor, demonstrating synergistic effects. To further evaluate the efficacy and safety of sunitinib and olaparib combined with epalolide and torvocizumab in neoadjuvant treatment for these patients, a prospective, multicenter, single-arm exploratory study is planned to provide valuable insights for developing neoadjuvant treatment regimens for advanced ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Medication Regimen | Experimental | Drug: Sunitinib、Olaparib、Tolilizumab1. 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunitinib、Olaparib、Tolilizumab1. 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 | Study Medication Regimen |
Primary outcome
Total resection rate (R0 resection rate)
Time frame: 3-month
All macroscopically visible tumor tissues were surgically removed, and no cancer cells were found at the surgical margins under microscopic examination.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: 12-month
Disease Control Rate (DCR)
Time frame: 12-month
Progression-Free Survival (PFS)
Time frame: 12-month
Pathological Complete Response rate (pCR rate)
Time frame: 12-month
Overall Survival (OS)
Time frame: 12-month
Adverse Events (AEs)
Time frame: 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yao Chen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib、Olaparib、Tolilizumab in people with Ovary Cancer, run by Bai-Rong Xia at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bai-Rong Xia, MD (18604516165, xiabairong9999@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total resection rate (R0 resection rate) (time frame: 3-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.