Triple-Drug cocktail aims to boost ovarian cancer surgery success
NCT ID NCT07667751
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a combination of three drugs—ipalotinib, sunitinib, and olaparib—given before surgery to people with a specific type of advanced ovarian cancer (HRD-positive). The goal is to shrink tumors enough to allow complete removal during surgery. The study will enroll 35 participants and track how many achieve complete tumor removal, as well as safety and response rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ipalotinib (Tislelizumab), sunitinib, and olaparib
- What this could lead to
- If successful, this combination could improve the rate of complete tumor removal during surgery for advanced ovarian cancer, potentially leading to better outcomes.
- What could go wrong
- This is a small, early-phase study with only 35 participants and no comparison group. The drug combination may cause significant side effects, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female participants aged ≥18 years and ≤75 years at enrollment; 2. 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; 3. 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); 4. Positive HRD testing result; 5. Presence of at least one measurable lesion meeting RECIST 1.1 criteria; 6. Expected survival time ≥12 weeks; 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 8. 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): 1. Complete blood count: HGB ≥ 90 g/L; WBC ≥ 4.0 × 10⁹/L; NEUT ≥ 2.0 × 10⁹/L; PLT ≥ 100 × 10⁹/L; 2. Blood biochemistry: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; BUN and Cr ≤ 1.5 × ULN with creatinine clearance ≥ 50 mL/min; 3. Coagulation function: INR ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN; 4. Within 4 weeks prior to the first dose, cardiac ultrasound must demonstrate: left ventricular ejection fraction (LVEF)\> 50%; 9. Pregnancy test results must be negative in patients of childbearing age, with voluntary use of effective and reliable contraceptive measures during the study; 10. Participants must voluntarily enroll in the study, sign an informed consent form, demonstrate good compliance, and agree to participate in follow-up visits. Exclusion Criteria: 1. 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; 2. 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); 3. 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); 4. Participation in other drug clinical trials and use of investigational drugs within 4 weeks prior to enrollment; 5. Administration of live attenuated vaccines within 4 weeks before initial dosing or planned during the study period; 6. Known history of allergy to any component of this regimen; 7. Subjects with active infectious diseases; 8. Subjects with any severe and/or uncontrolled diseases; 9. 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; 10. Pregnant or breastfeeding women, or women of childbearing potential with positive baseline pregnancy test results. 11. 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; 12. A documented history of neurological or psychiatric disorders, including epilepsy or dementia; 13. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 14. Known history of interstitial lung disease or non-infectious pneumonia; 15. Diagnosis of immunodeficiency or ongoing systemic glucocorticoid therapy or any other form of immunosuppressive treatment; 16. Presence of any condition increasing bleeding risk, such as severe hemorrhoids, acute gastritis, or gastric and duodenal ulcers; 17. History of dysphagia or any gastrointestinal disorder affecting drug absorption; 18. Any other circumstances deemed inappropriate for study participation by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anhui Cancer Hospital
RECRUITINGHefei, China
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