招募中 NCT06367270

加壓腹腔氣霧化療(PIPAC)在腹膜表面惡性腫瘤中的應用

大腸直腸癌卵巢癌胰臟癌Phase II

加壓腹腔氣霧化療(PIPAC)是一種用於腹膜轉移(PM)患者的新型微創藥物遞送系統。先前的第一期研究已證明其為一種安全且可行的紓緩治療替代方案。目前關於其在亞洲人群中可行性、療效及耐受性的證據有限。

適應症:Peritoneal Metastases

收案條件

納入條件

  • ≥18 years of old;
  • WHO performance of status 0-1;
  • Histologically or cytologically proven PM of a gastric, pancreatic or colorectal carcinoma;
  • Treatment naïve patients as first-line treatment;
  • Progression on or intolerance to first-line systemic chemotherapy as second-line treatment;
  • No symptoms of gastrointestinal obstruction;
  • No contraindications for the planned systemic therapy or laparoscopy;
  • No previous PIPAC/IP/HIPEC;
  • No other concurrent malignancies or any other malignancy within 6 months prior to enrolment;
  • Able to give written informed consent.

排除條件

  • A history of allergic reaction to platinum containing compounds or doxorubicin;
  • Pregnant or breastfeeding;
  • Any extra-peritoneal metastases;
  • Renal impairment, defined as GFR less than 40 mL/min;
  • Impaired liver function defined as bilirubin over 1.5 × UNL;
  • Inadequate haematological function
  • Leucocyte \< 3.00 × 109/L
  • Absolute neutrophil counts \< 1.50 × 109/L
  • Platelet \< 100 × 109/L

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。