Could a single chemo drug replace the standard doublet for some ovarian cancers?
NCT ID NCT07401654
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a single chemotherapy drug (paclitaxel) to the standard two-drug combo (paclitaxel plus carboplatin) as initial treatment before surgery for advanced ovarian cancer. It is for patients whose tumors have high levels of a protein called PARK2, which may make them more sensitive to paclitaxel. The goal is to see if the single drug works just as well but causes fewer side effects and delays resistance to platinum drugs. About 60 women will take part.
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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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- 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: * Female patients aged 18-75 years. * Histologically confirmed FIGO Stage III-IV high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer via laparotomy, laparoscopy, or core needle biopsy. * Presence of at least one measurable lesion on CT/MRI, meeting at least one of the following conditions: * Failure to achieve R0 cytoreduction (Fagotti score ≥ 8 or upper abdominal CT score ≥ 3). * Presence of factors indicating surgical intolerance (meeting ≥1 item): Age ≥75 years; BMI ≥40; Chronic underlying diseases; Malnutrition or hypoalbuminemia; Moderate to large volume ascites; Newly diagnosed venous thromboembolism; ECOG performance status \>2. * High expression of the PARK2 gene in both tumor tissue and blood (Spatial Imaging \[SI\] score in tumor tissue ≥ 7). * Expected survival time \> 12 weeks. * ECOG performance status of 0-2. * Adequate organ function meeting the following criteria: * Bone Marrow Function: Absolute neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10⁹/L); Platelet count ≥ 100,000/mm³ (100 × 10⁹/L); Hemoglobin ≥ 10 g/dL (100 g/L). * Liver Function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Direct bilirubin ≤ 1 × ULN; AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present). * Renal Function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula). * For women of childbearing potential: * Negative pregnancy test within 1 week prior to enrollment. * Agreement to use effective non-hormonal contraception (e.g., barrier method/intrauterine device) during the study period. * Not currently breastfeeding. * Recovery from prior chemotherapy-related toxicities to ≤ Grade 1 per CTCAE (or baseline level), except for stable sensory neuropathy or alopecia (which may be ≤ Grade 2). * Willingness to provide tissue and blood samples during the treatment period. * Ability to understand and voluntarily comply with the study protocol requirements, including: * Adherence to the prescribed treatment schedule. * Completion of required laboratory tests and imaging assessments per protocol. * Participation in the planned follow-up procedures. * Willingness to complete quality of life questionnaire assessments. Exclusion Criteria: * Individuals involved in the planning or conduct of this study. * Patients concurrently participating in other clinical trials, using other investigational drugs, or receiving neoadjuvant therapies (chemotherapy/radiotherapy/immunotherapy/traditional Chinese medicine therapy). * Known hypersensitivity or allergy to paclitaxel or carboplatin. * Patients with dysphagia or gastrointestinal disorders that could affect drug absorption, distribution, metabolism, or excretion (ADME). * Active symptomatic brain metastases requiring surgery, radiation, and/or corticosteroid therapy, or patients with clinical signs of spinal cord compression. * Major surgery within 3 weeks prior to study initiation without full recovery. * Previous or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or other primary malignancies (except for adequately treated basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix). * Diseases or conditions associated with a high risk of toxicity, including: * HIV infection, active hepatitis B or C. * Severe cardiovascular diseases (e.g., refractory ventricular arrhythmia, myocardial infarction within the past 3 months). * Uncontrolled grand mal seizures, unstable spinal cord compression, or superior vena cava syndrome. * Psychiatric illness that would impair the patient's ability to provide informed consent. * Uncontrolled hypertension or any other condition deemed by the investigator to be unsuitable for study participation. * Prior medical history or existing clinical conditions that may interfere with the interpretation of study results or patient compliance. * Transfusion of platelets or red blood cells within 3 days prior to the start of study drug administration. * Unresolved clinical toxicities ≥ Grade 2 (except for neuralgia, lymphopenia, and skin depigmentation).
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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 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
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