顺铂和多柔比星联合加压腹腔内气溶胶化疗（PIPAC）联合 FOLFOX 化疗作为胃腺癌伴腹膜转移患者一线治疗的单臂 II 期研究。
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study.
机构信息
Clinic of Gastroenterology, Nephrourology, and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania, Ciurlionio str. 21, 03101.
Department of Abdominal Surgery and Oncology, National Cancer Institute, Vilnius, Lithuania.
出版信息
BMC Cancer. 2023 Oct 25;23(1):1032. doi: 10.1186/s12885-023-11549-z.
BACKGROUND
Gastric cancer (GC) remains among the most common and most lethal cancers worldwide. Peritoneum is the most common site for distant dissemination. Standard treatment for GC peritoneal metastases (PM) is a systemic therapy, but treatment outcomes remain very poor, with median overall survival ranging between 3-9 months. Thus, novel treatment methods are necessary. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is the most novel technique for intraperitoneal chemotherapy. Some preliminary data suggest PIPAC can achieve improved long-term outcomes in patients with GC PM, especially when used in combination with systemic chemotherapy. However, there is a lack of data from well-design prospective studies that would confirm the efficacy of PIPAC and systemic therapy combination for first-line treatment.
METHODS
This study is an investigator-initiated single-arm, phase II trial to investigate the efficacy of PIPAC combined with systemic FOLFOX (5-fluorouracil, oxaliplatin, leucovorin) as a first-line treatment for GC PM. The study is conducted in 2 specialized GC treatment centers in Lithuania. It enrolls GC patients with histologically confirmed PM without prior treatment. The treatment protocol consists of PIPAC with cisplatin (10.5 mg/m2 body surface in 150 mL NaCl 0.9%) and doxorubicin (2.1 mg/m2 in 50 mL NaCl 0.9%) followed by 2 cycles of FOLFOX every 6-7 weeks. In total 3 PIPACs and 6 cycles of FOLFOX will be utilized. The primary outcome of the study is the objective response rate (ORR) according to RECIST v. 1.1 criteria (Eisenhauer et al., Eur J Cancer 45:228-47) in a CT scan performed 7 days after the 4 cycle of FOLFOX. Secondary outcomes include ORR after all experimental treatment, PIPAC characteristics, postoperative morbidity, histological and biochemical response, ascites volume, quality of life, overall survival, and toxicity.
DISCUSSION
This study aims to assess PIPAC and FOLFOX combination efficacy for previously untreated GC patients with PM.
TRIAL REGISTRATION
NCT05644249. Registered on December 9, 2022.
背景
胃癌（GC）仍然是全球最常见和最致命的癌症之一。腹膜是远处转移最常见的部位。GC 腹膜转移（PM）的标准治疗是全身治疗，但治疗效果仍然很差，中位总生存期在 3-9 个月之间。因此，需要新的治疗方法。腹腔内加压气溶胶化疗（PIPAC）是腹腔内化疗的最新技术。一些初步数据表明，PIPAC 可以改善 GC PM 患者的长期预后，特别是当与全身化疗联合使用时。然而，缺乏来自精心设计的前瞻性研究的数据来证实 PIPAC 与全身治疗联合作为一线治疗的疗效。
方法
这是一项由研究者发起的单臂、二期临床试验，旨在研究 PIPAC 联合全身 FOLFOX（氟尿嘧啶、奥沙利铂、亚叶酸钙）作为 GC PM 一线治疗的疗效。该研究在立陶宛的 2 个专门的 GC 治疗中心进行。它招募了未经治疗的组织学证实的 PM 胃癌患者。治疗方案包括顺铂（10.5mg/m2 体表面积，在 150ml NaCl 0.9%中）和多柔比星（2.1mg/m2，在 50ml NaCl 0.9%中）的 PIPAC，随后每 6-7 周进行 2 个周期的 FOLFOX。总共进行 3 次 PIPAC 和 6 个周期的 FOLFOX。该研究的主要终点是根据 RECIST v.1.1 标准（Eisenhauer 等人，Eur J Cancer 45:228-47）在第 4 个 FOLFOX 周期后 7 天进行 CT 扫描时的客观缓解率（ORR）。次要终点包括所有实验治疗后的 ORR、PIPAC 特征、术后发病率、组织学和生化反应、腹水体积、生活质量、总生存期和毒性。
讨论
本研究旨在评估 PIPAC 和 FOLFOX 联合治疗未经治疗的 GC 伴 PM 患者的疗效。
试验注册
NCT05644249。于 2022 年 12 月 9 日注册。
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