[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613961":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":11,"responsibleParty":30,"collaborators":11,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":11,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":11,"studyType":46,"phases":47,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":11},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PIPAC-OVPAC group","EXPERIMENTAL",null,[13],"Drug: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel","All patients enrolled in this study receive PIPAC using paclitaxel under 12 mmHg at 6 weeks intervals (up to 9 cycles)\n\n1. Phase 1 Design\n\n   1. Dose Escalation: Standard 3+3 design across 5 paclitaxel cohorts (20 → 40 → 67 → 100 → 140 mg\u002Fm²) using modified Fibonacci increments (100%, 67%, 50%, 40%).\n   2. Maximum tolerated dose(MTD) Determination\n\n      * If ≥2\u002F6 patients in cohort χ experience dose limiting toxicities(DLTs; Grade ≥3 toxicity per CTCAE v5.0, excluding manageable pain) and ≤1\u002F6 in cohort χ-1, MTD = χ-1.\n      * If no DLTs at 140 mg\u002Fm², Phase 1 concludes.\n   3. Dose Reduction\n\n      * DLTs in 20 mg\u002Fm² trigger de-escalation to 10 mg\u002Fm².\n      * If ≤1\u002F6 DLTs in 10 mg\u002Fm² → RP2D; ≥2\u002F6 DLTs → trial termination.\n2. Phase 2 Design : Evaluates efficacy\u002Fsafety of PIPAC at the RP2D in 23 patients, adjusting for 5-17% laparoscopic access failure.",[9],[21],{"name":22,"affiliation":23,"role":24},"Hee Seung Kim, MD, PhD","Seoul National University College of Medicine","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":11,"email":29},"CONTACT","82-02-2072-4863","bboddi0311@snu.ac.kr",{"type":24,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Hee Seung Kim","Professor","100613961","phase-1-tolerance-safety-efficacy-and-pharmacokinetics-of-pressurized-intraperitoneal-aerosol-chemotherapy-pipac-using-paclitaxel-for-platinum-resistant-recurrent-ovarian-cancer-100613961",false,"NCT07273396","Tolerance, Safety, Efficacy, and Pharmacokinetics of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel for Platinum-resistant Recurrent Ovarian Cancer","A Phase 1\u002F2a 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\u002F2a)","Inclusion Criteria:\n\n1. Age: Women aged 19-85 years.\n2. Diagnosis: Histologically confirmed ovarian, fallopian tube, or peritoneal cancer.\n3. Platinum Status:\n\n   * Refractory: Disease progression during platinum-based chemotherapy.\n   * Resistant: Progression within 6 months (24 weeks) post-platinum therapy.\n4. Prior Therapies: ≥2 prior intravenous chemotherapies (may include paclitaxel).\n5. Treatment Options: Unresponsive to\u002Fineligible for standard therapies (e.g., intolerance, hypersensitivity) and ineligible for surgical resection.\n6. Measurable Disease: ≥1 measurable\u002Fevaluable peritoneal lesion per RECIST 1.1.\n7. Metastasis: ≤1 asymptomatic distant metastasis (excluding retroperitoneal lymph nodes, pleural effusion, localized skin metastases).\n8. Imaging Confirmation: Peritoneal carcinomatosis confirmed by PET-CT\u002FCT.\n9. Performance Status: ECOG 0-2.\n10. Pregnancy\u002FContraception:\n\n    * Non-pregnant\u002Fnon-lactating.\n    * Contraception: Effective methods (IUD, sterilization) for 6 months post-PIPAC (childbearing potential only).\n11. Organ Function:\n\n    * Bone Marrow: ANC \\>1,500\u002Fmm³, platelets \\>100,000\u002Fmm³, hemoglobin \\>8.0 g\u002FdL.\n    * Liver: Bilirubin ≤1.5×ULN, AST\u002FALT ≤1.5×ULN.\n    * Kidney: Creatinine ≤1.5×ULN, creatinine clearance \\>60 mL\u002Fmin.\n    * Lungs: FVC\u002FFEV1 ≥70% predicted.\n    * Coagulation: INR ≤1.5, aPTT ≤1.5×ULN.\n12. Consent: Signed informed consent.\n\nExclusion Criteria:\n\n1. ≥2 distant metastases (excluding retroperitoneal lymph nodes, pleural effusion, and localized skin metastases).\n2. Contraindications to paclitaxel per approved domestic labeling.\n3. Hypersensitivity history to paclitaxel or PIPAC devices.\n4. Uncontrolled comorbidities per investigator judgment:\n\n   * NYHA Class ≥II heart failure\n   * Clinically significant cardiovascular disease (e.g., arrhythmia, myocardial infarction)\n   * Immunosuppressive conditions (AIDS, autoimmune diseases, immunosuppressive therapy)\n   * Active HBV\u002FHCV infection\n   * Uncontrolled hypertension (systolic \\>160 mmHg or diastolic \\>100 mmHg)\n   * Uncontrolled diabetes (HbA1c \\>8%)\n   * Radiographic\u002Fclinical bowel obstruction.\n5. IV chemotherapy within 4 weeks prior to Cycle 1 PIPAC.\n6. Life expectancy \\\u003C3 months.\n7. Prior PIPAC therapy.\n8. Medically unfit for general anesthesia or laparoscopic surgery.\n9. Refusal of contraception:\n\n   \\- Medically acceptable methods:\n   * Intrauterine device (failure rate \\\u003C1%)\n   * Surgical sterilization (tubal ligation, hysterectomy, vasectomy; failure rate \\\u003C0.5%).\n10. Participation in another clinical trial within 1 month of screening.\n11. Other exclusionary factors per investigator discretion.","FEMALE","19 Years","85 Years",{"count":44,"type":45},53,"ESTIMATED","INTERVENTIONAL",[48,49],"PHASE1","PHASE2","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.",[52,53],"Ovarian Neoplasms","Peritoneal Neoplasms",[55,56,57,58],"Pressurized intraperitoneal aerosol chemotherapy","platinum-resistant recurrent","ovarian cancer","paclitaxel","NOT_YET_RECRUITING","2025-11-27",{"date":62,"type":63},"2025-12-09","ACTUAL",{"date":65,"type":45},"2026-01-01",{"date":67,"type":45},"2030-08-31",{"name":5,"class":6}]