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

Korábbi kezelés

• IV chemotherapy within 4 weeks prior to Cycle 1 PIPAC.
• Prior PIPAC therapy.
• Medically unfit for general anesthesia or laparoscopic surgery.

Más betegség

• Hypersensitivity history to paclitaxel or PIPAC devices.
• Refusal of contraception:
  • Medically acceptable methods:
  • Intrauterine device (failure rate <1%)
  • Surgical sterilization (tubal ligation, hysterectomy, vasectomy; failure rate <0.5%).

Laborértékek

• 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.

Egyéb

• ≥2 distant metastases (excluding retroperitoneal lymph nodes, pleural effusion, and localized skin metastases).
• Contraindications to paclitaxel per approved domestic labeling.
• Life expectancy <3 months.
• Participation in another clinical trial within 1 month of screening.
• Other exclusionary factors per investigator discretion.

• 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.