招募中 NCT06367270

加压腹腔气雾化疗(PIPAC)在腹膜表面恶性肿瘤中的应用

结直肠癌卵巢癌胰腺癌Phase II

加压腹腔气雾化疗(PIPAC)是一种用于腹膜转移(PM)患者的新型微创药物递送系统。先前的第一期研究已证明其为一种安全且可行的姑息治疗替代方案。目前关于其在亚洲人群中可行性、疗效及耐受性的证据有限。

适应症:Peritoneal Metastases

入组条件

纳入标准

  • ≥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.

排除标准

  • 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

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。