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New spray chemotherapy trial targets Hard-to-Treat ovarian cancer

NCT ID NCT07273396

Disease control Sponsor: Seoul National University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a method called PIPAC, where the chemotherapy drug paclitaxel is turned into a pressurized spray and delivered directly into the abdomen. It is for women with ovarian cancer that has come back and no longer responds to platinum-based chemotherapy. The trial has two phases: first to find the safest dose, then to see how well it controls the disease. About 53 women will take part, receiving the treatment every six weeks for up to nine cycles.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
paclitaxel
What this could lead to
If successful, this could offer a new treatment option for women with ovarian cancer that has spread to the abdomen and no longer responds to standard chemotherapy.
What could go wrong
This is an early-phase trial with only 53 participants, so results may not apply broadly. The chemotherapy is given as a gas under pressure, which carries risks like toxicity or pain, and the cancer may still progress.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 53 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

Aug 2030

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

19 to 85 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: 1. Age: Women aged 19-85 years. 2. Diagnosis: Histologically confirmed ovarian, fallopian tube, or peritoneal cancer. 3. Platinum Status: * Refractory: Disease progression during platinum-based chemotherapy. * Resistant: Progression within 6 months (24 weeks) post-platinum therapy. 4. Prior Therapies: ≥2 prior intravenous chemotherapies (may include paclitaxel). 5. Treatment Options: Unresponsive to/ineligible for standard therapies (e.g., intolerance, hypersensitivity) and ineligible for surgical resection. 6. Measurable Disease: ≥1 measurable/evaluable peritoneal lesion per RECIST 1.1. 7. Metastasis: ≤1 asymptomatic distant metastasis (excluding retroperitoneal lymph nodes, pleural effusion, localized skin metastases). 8. Imaging Confirmation: Peritoneal carcinomatosis confirmed by PET-CT/CT. 9. Performance Status: ECOG 0-2. 10. Pregnancy/Contraception: * Non-pregnant/non-lactating. * Contraception: Effective methods (IUD, sterilization) for 6 months post-PIPAC (childbearing potential only). 11. Organ Function: * Bone Marrow: ANC \>1,500/mm³, platelets \>100,000/mm³, hemoglobin \>8.0 g/dL. * Liver: Bilirubin ≤1.5×ULN, AST/ALT ≤1.5×ULN. * Kidney: Creatinine ≤1.5×ULN, creatinine clearance \>60 mL/min. * Lungs: FVC/FEV1 ≥70% predicted. * Coagulation: INR ≤1.5, aPTT ≤1.5×ULN. 12. Consent: Signed informed consent. Exclusion Criteria: 1. ≥2 distant metastases (excluding retroperitoneal lymph nodes, pleural effusion, and localized skin metastases). 2. Contraindications to paclitaxel per approved domestic labeling. 3. Hypersensitivity history to paclitaxel or PIPAC devices. 4. Uncontrolled comorbidities per investigator judgment: * NYHA Class ≥II heart failure * Clinically significant cardiovascular disease (e.g., arrhythmia, myocardial infarction) * Immunosuppressive conditions (AIDS, autoimmune diseases, immunosuppressive therapy) * Active HBV/HCV infection * Uncontrolled hypertension (systolic \>160 mmHg or diastolic \>100 mmHg) * Uncontrolled diabetes (HbA1c \>8%) * Radiographic/clinical bowel obstruction. 5. IV chemotherapy within 4 weeks prior to Cycle 1 PIPAC. 6. Life expectancy \<3 months. 7. Prior PIPAC therapy. 8. Medically unfit for general anesthesia or laparoscopic surgery. 9. Refusal of contraception: \- Medically acceptable methods: * Intrauterine device (failure rate \<1%) * Surgical sterilization (tubal ligation, hysterectomy, vasectomy; failure rate \<0.5%). 10. Participation in another clinical trial within 1 month of screening. 11. Other exclusionary factors per investigator discretion.

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Conditions

The condition(s) this trial relates to.

ovarian cancer ovarian carcinoma ovarian neoplasm peritoneal carcinomatosis peritoneal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian neoplasms Peritoneal neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.