City of Hope Comprehensive Cancer Center, 1500 E Duarte Road, Duarte, CA 91010, USA.
City of Hope Beckman Research Institute, 1500 E Duarte Road, Duarte, CA 91010, USA.
Future Oncol. 2024;20(33):2521-2531. doi: 10.1080/14796694.2024.2394013. Epub 2024 Sep 12.
Biliary tract cancers are a rare diagnosis with a rising incidence. Up to 20% of patients have peritoneal metastases, resulting in symptoms of ascites, abdominal pain and potential bowel obstruction. A standard of care systemic treatment comprises gemcitabine, cisplatin and durvalumab (gem/cis/durva). However, the clinical benefit among patients with peritoneal metastases remains unknown. Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) delivers chemotherapy directly to the peritoneal space, which could potentially improve efficacy with minimal systemic toxicity. We describe the design of a Phase I study investigating PIPAC with nab-paclitaxel plus systemic gem/cis/durva among biliary tract cancer patients with peritoneal metastases who have not received prior systemic treatment. The primary end point is safety of PIPAC with nab-paclitaxel in combination with systemic gem/cis/durva. NCT05285358 (ClinicalTrials.gov).
胆道癌的诊断较为罕见，但发病率呈上升趋势。多达 20%的患者发生腹膜转移，导致腹水、腹痛和潜在肠梗阻等症状。吉西他滨、顺铂和度伐利尤单抗（gem/cis/durva）构成了一种标准的系统治疗方法。然而，腹膜转移患者的临床获益仍不清楚。加压腹腔内雾化化疗（PIPAC）将化疗药物直接输送到腹膜腔，可能会在最小化全身毒性的情况下提高疗效。我们描述了一项 I 期研究的设计，该研究调查了nab-紫杉醇联合系统 gem/cis/durva 治疗未经系统治疗的胆道癌腹膜转移患者的 PIPAC 的安全性。主要终点是 PIPAC 联合 nab-紫杉醇与系统 gem/cis/durva 的安全性。NCT05285358（ClinicalTrials.gov）。
