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Could a single chemo drug replace the standard doublet for some ovarian cancers?

NCT ID NCT07401654

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Female participants only

Healthy volunteers

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

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

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