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Ovarian NeoplasmsPhase 1/2NCT07273396

Tolerance, Safety, Efficacy, and Pharmacokinetics of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel for Platinum-resistant Recurrent Ovarian Cancer

A Phase 1/2 study testing Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel in people with Ovarian Neoplasms and Peritoneal Neoplasms, run by Seoul National University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the tolerance, safety, efficacy, and pharmacokinetics of pressurized intraperitoneal aerosol chemotherapy (PIPAC) with paclitaxel in patients with platinum-resistant recurrent ovarian cancer and peritoneal carcinomatosis. Read more about this study

Who is it for?
Ages 19 to 85 years, women only
Conditions the study is for
Ovarian Neoplasms, Peritoneal Neoplasms
What is being tested?
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
No sites listed yet
Study dates
1 Jan 2026to 31 Aug 2030
Phase
Phase 1/2
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 19 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: Women aged 19-85 years.
  • Diagnosis: Histologically confirmed ovarian, fallopian tube, or peritoneal cancer.
  • Platinum Status:
  • Refractory: Disease progression during platinum-based chemotherapy.
  • Resistant: Progression within 6 months (24 weeks) post-platinum therapy.
  • Prior Therapies: ≥2 prior intravenous chemotherapies (may include paclitaxel).
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  • Treatment Options: Unresponsive to/ineligible for standard therapies (e.g., intolerance, hypersensitivity) and ineligible for surgical resection.
  • Measurable Disease: ≥1 measurable/evaluable peritoneal lesion per RECIST 1.1.
  • Metastasis: ≤1 asymptomatic distant metastasis (excluding retroperitoneal lymph nodes, pleural effusion, localized skin metastases).
  • Imaging Confirmation: Peritoneal carcinomatosis confirmed by PET-CT/CT.
  • Performance Status: ECOG 0-2.
  • Pregnancy/Contraception:
  • Non-pregnant/non-lactating.
  • Contraception: Effective methods (IUD, sterilization) for 6 months post-PIPAC (childbearing potential only).
  • 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.
  • Consent: Signed informed consent.

Who cannot join

  • ≥2 distant metastases (excluding retroperitoneal lymph nodes, pleural effusion, and localized skin metastases).
  • Contraindications to paclitaxel per approved domestic labeling.
  • Hypersensitivity history to paclitaxel or PIPAC devices.
  • Uncontrolled comorbidities per investigator judgment:
  • NYHA Class ≥II heart failure
  • Clinically significant cardiovascular disease (e.g., arrhythmia, myocardial infarction)
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  • 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.
  • IV chemotherapy within 4 weeks prior to Cycle 1 PIPAC.
  • Life expectancy <3 months.
  • Prior PIPAC therapy.
  • Medically unfit for general anesthesia or laparoscopic surgery.
  • Refusal of contraception:
  • Medically acceptable methods:
  • Intrauterine device (failure rate <1%)
  • Surgical sterilization (tubal ligation, hysterectomy, vasectomy; failure rate <0.5%).
  • Participation in another clinical trial within 1 month of screening.
  • Other exclusionary factors per investigator discretion.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hee Seung Kim, MD, PhD contact

82-02-2072-4863

bboddi0311@snu.ac.kr

About this study

Official title: A Phase 1/2a Study to Evaluate the Tolerance, Safety, Efficacy, and Pharmacokinetics of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel for Platinum-resistant Recurrent Ovarian Cancer With Peritoneal Metastasis (PIPAC-OVPAC 1/2a)

The purpose of this study is to evaluate the tolerance, safety, efficacy, and pharmacokinetics of pressurized intraperitoneal aerosol chemotherapy (PIPAC) with paclitaxel in patients with platinum-resistant recurrent ovarian cancer and peritoneal carcinomatosis.

Read the detailed description

The Study Design is an interventional, non-randomized, sequential Phase 1/2a trial, where patients with platinum-resistant recurrent ovarian cancer(PROC) and radiologically confirmed peritoneal carcinomatosis will be enrolled.

All patients included in this study will receive PIPAC, laparoscopic aerosolization of paclitaxel under 12 mmHg pressure at 6-week intervals (up to 9 cycles) for treating PROC with peritoneal metastasis.

Being tested
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel
Keywords
Pressurized intraperitoneal aerosol chemotherapy, platinum-resistant recurrent, ovarian cancer, paclitaxel
Medical subject headings
Ovarian Neoplasms, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxelDrug

    All patients enrolled in this study receive PIPAC using paclitaxel under 12 mmHg at 6 weeks intervals (up to 9 cycles)

    1. Phase 1 Design
    2. Dose Escalation: Standard 3+3 design across 5 paclitaxel cohorts (20 → 40 → 67 → 100 → 140 mg/m²) using modified Fibonacci increments (100%, 67%, 50%, 40%).
    3. Maximum tolerated dose(MTD) Determination
    • If ≥2/6 patients in cohort χ experience dose limiting toxicities(DLTs; Grade ≥3 toxicity per CTCAE v5.0, excluding manageable pain) and ≤1/6 in cohort χ-1, MTD = χ-1.
    • If no DLTs at 140 mg/m², Phase 1 concludes.
    1. Dose Reduction
    • DLTs in 20 mg/m² trigger de-escalation to 10 mg/m².
    • If ≤1/6 DLTs in 10 mg/m² → RP2D; ≥2/6 DLTs → trial termination.
    1. Phase 2 Design : Evaluates efficacy/safety of PIPAC at the RP2D in 23 patients, adjusting for 5-17% laparoscopic access failure.
Study groups in NCT07273396
Study groupRoleWhat they receive
PIPAC-OVPAC groupExperimentalNot described
Receives: Drug: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicities

    Dose limiting toxicities

    Measured: Till 6 weeks after the first PIPAC in phase 1 study

  2. Maximum tolerated dose

    We consider dose escalation if 3 consecutive DLTs do not occur, or less than 1 in 6 DLTs occur, per standard 3+3 design. If DLT occurs in 2 or more of 6, the lower dose is considered the MTD if 1 or fewer DLTs are identified. In addition, the highest dose (140 mg/m2) is considered the MTD when 3 to 0 DLTs or 6 to 1 DLTs are identified at the highest dose. On the other hand, if the initial dose (20 mg/m2) is reduced to 10 mg/m2 to account for DLT, it is considered the MTD if no more than 1 in 6 develop DLT at that reduced dose.

    Measured: During phase 1 study (up to 6 weeks)

  3. Recommended Phase 2 Dose

    Recommended Phase 2 Dose determined by dose limiting toxicities

    Measured: During phase 1 study

  4. Disease control rate

    Disease control rate at the 9-week time point

    Measured: During phase 2 study

Secondary outcomes (15)

  1. Maximum concentration (Cmax)

    Cmax on pharmacokinetic evaluation of paclitaxel administered via pressurized intraperitoneal aerosol chemotherapy

    Measured: During phase 1 study

  2. Time at which Cmax is observed (Tmax)

    Tmax on pharmacokinetic evaluation of paclitaxel administered via pressurized intraperitoneal aerosol chemotherapy

    Measured: During phase 1 study

  3. Area under the curve (AUC)

    AUC on pharmacokinetic evaluation of paclitaxel administered via pressurized intraperitoneal aerosol chemotherapy

    Measured: During phase 1 study

  4. Disease control rate

    Disease control rate at the 9-week time point

    Measured: During phase 1 study

  5. Progression-free survival

    Time from the treatment start of pressurized intraperitoneal aerosol chemotherapy to the identification of progressive disease or the end of the study

    Measured: During phase 1 and 2a studies

  6. Overall survival

    Time from the treatment start of pressurized intraperitoneal aerosol chemotherapy to cancer-related death or the end of the study

    Measured: During phase 1 and 2a studies

  7. Peritoneal cancer index

    Peritoneal cancer index scores identified during pressurized intraperitoneal aerosol chemotherapy, which range from 0 to 39

    Measured: During phase 1 and 2a studies

  8. Peritoneal Regression Grading Score

    Peritoneal Regression Grading Score examined by pathologic review; Peritoneal Regression Grading Score 1, complete response: Peritoneal Regression Grading Score 2, major response: Peritoneal Regression Grading Score 3, minor response; Peritoneal Regression Grading Score 4, no response

    Measured: During phase 1 and 2a studies

  9. Changes in ascites volume

    Changes in ascites volume measured during pressurized intraperitoneal aerosol chemotherapy

    Measured: During phase 1 and 2a studies

  10. CA-125

    Seum CA-125 levels, which are related to disease progression when more than 35 U/ml

    Measured: Assessed at every visit during the study period

  11. human epididymis protein 4 (HE4)

    Serum HE4 levels, which are related to disease progression when more than 140 pmol/L

    Measured: Assessed at every visit during the study period

  12. The Risk of Ovarian Malignancy Algorithm (ROMA) score

    ROMA score using serum CA-125 and HE4 levels, which are related to disease progression when more than 30%

    Measured: Assessed at every visit during the study period

  13. EORTC QLQ-C30 questionnaire

    EORTC QLQ-C30 questionnaires measured during the study. The evaluation range for each item is from 0 to 100.

    Measured: During phase 1 and 2a studies

  14. EORTC QLQ-OV28 questionnaire measured during the study

    EORTC QLQ-OV28 questionnaire measured during the study. The evaluation range for each item is from 0 to 100.

    Measured: During phase 1 and 2a studies

  15. Safety evaluation

    Safety evaluation per CTCAE v5.0, including treatment-related adverse events and surgical complications. The evaluation range for each item is from grade 1 to grade 5.

    Measured: During phase 1 and 2a studies

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion31 Aug 2030 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07273396
Sponsor's protocol ID
PIPAC-OVPAC-1/2a
Status last verified
Nov 2025
First submitted
5 May 2025
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel in people with Ovarian Neoplasms and Peritoneal Neoplasms, run by Seoul National University Hospital.

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 21 inclusion and 21 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: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Hee Seung Kim, MD, PhD (82-02-2072-4863, bboddi0311@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities (time frame: Till 6 weeks after the first PIPAC in phase 1 study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07273396.

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 9 Dec 2025.

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