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NCT Number: NCT07273396

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

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.

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Key information

Conditions

Ovarian Neoplasms Abdominal Neoplasms Adnexal Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Peritoneal Diseases Peritoneal Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • 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.

Exclusion criteria

  • ≥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)
  • 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.

Treatment and study plan

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel

Drug

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

  • Phase 1 Design
  • 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%).
  • 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.
  • 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.
  • Phase 2 Design : Evaluates efficacy/safety of PIPAC at the RP2D in 23 patients, adjusting for 5-17% laparoscopic access failure.

Primary outcomes

  1. Dose limiting toxicities

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

    Dose limiting toxicities

  2. Maximum tolerated dose

    Time frame: During phase 1 study (up to 6 weeks)

    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.

  3. Recommended Phase 2 Dose

    Time frame: During phase 1 study

    Recommended Phase 2 Dose determined by dose limiting toxicities

  4. Disease control rate

    Time frame: During phase 2 study

    Disease control rate at the 9-week time point

Secondary outcomes

  1. Maximum concentration (Cmax)

    Time frame: During phase 1 study

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

  2. Time at which Cmax is observed (Tmax)

    Time frame: During phase 1 study

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

  3. Area under the curve (AUC)

    Time frame: During phase 1 study

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

  4. Disease control rate

    Time frame: During phase 1 study

    Disease control rate at the 9-week time point

  5. Progression-free survival

    Time frame: During phase 1 and 2a studies

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

  6. Overall survival

    Time frame: During phase 1 and 2a studies

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

  7. Peritoneal cancer index

    Time frame: During phase 1 and 2a studies

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

  8. Peritoneal Regression Grading Score

    Time frame: During phase 1 and 2a studies

    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

  9. Changes in ascites volume

    Time frame: During phase 1 and 2a studies

    Changes in ascites volume measured during pressurized intraperitoneal aerosol chemotherapy

  10. CA-125

    Time frame: Assessed at every visit during the study period

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

  11. human epididymis protein 4 (HE4)

    Time frame: Assessed at every visit during the study period

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

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

    Time frame: Assessed at every visit during the study period

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

  13. EORTC QLQ-C30 questionnaire

    Time frame: During phase 1 and 2a studies

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

  14. EORTC QLQ-OV28 questionnaire measured during the study

    Time frame: During phase 1 and 2a studies

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

  15. Safety evaluation

    Time frame: During phase 1 and 2a studies

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hee Seung Kim, MD, PhD

CONTACT

[email protected]

82-02-2072-4863

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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