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。