Backgroud:Ovarian cancer is the deadliest gynecologic malignancy, with most patients presenting with peritoneal dissemination at diagnosis. Complete cytoreduction and sensitivity to platinum-based systemic chemotherapy remain the most significant prognostic factors. However, even after optimal first-line management, over half of patients relapse due to residual microscopic disease. Intraperitoneal chemotherapy aims to target this component, with normothermic intraperitoneal chemotherapy long-term (NIPEC-LT) and hyperthermic intraperitoneal chemotherapy (HIPEC) being the most studied approaches. While NIPEC-LT has demonstrated improved survival in select trials, concerns regarding toxicity and catheter-related complications have limited its adoption as standard care. Conversely, HIPEC has shown survival benefits, particularly in patients undergoing interval cytoreductive surgery (iCRS) after neoadjuvant chemotherapy, leading to its inclusion in clinical guidelines. However, HIPEC is administered as a single intraoperative treatment, limiting its prolonged effect.Objectives and Method: This study investigates the combination of HIPEC and postoperative NIPEC-LT in the BICOV-1 trial, a prospective, non-randomized phase I study evaluating the feasibility, safety, and oncologic outcomes. The primary objective is to assess the treatment completion rates and morbidity. The secondary endpoints include disease-free survival (DFS), overall survival (OS), and quality-of-life measures. Combining HIPEC and NIPEC-LT is a rational approach, as both have shown independent benefits and do not overlap in toxicity. HIPEC-induced biological changes may enhance the effectiveness of subsequent intraperitoneal chemotherapy. This trial will provide essential data for future phase II/III studies assessing the role of intensified intraperitoneal treatment in ovarian cancer management.
背景：卵巢癌是最致命的妇科恶性肿瘤，大多数患者在诊断时已出现腹膜播散。完全肿瘤细胞减灭术和对铂类全身化疗的敏感性仍是最重要的预后因素。然而，即使经过最佳的一线治疗，超过半数患者仍因残留的微小病灶而复发。腹腔内化疗旨在靶向这一残留病灶，其中长期常温腹腔化疗（NIPEC-LT）和热腹腔化疗（HIPEC）是研究最为深入的方法。尽管NIPEC-LT在部分试验中显示出生存获益，但其毒性和导管相关并发症的问题限制了其作为标准治疗的推广。相反，HIPEC已显示出生存优势，特别是在新辅助化疗后接受间歇性肿瘤细胞减灭术（iCRS）的患者中，这使其被纳入临床指南。然而，HIPEC作为单次术中治疗，其持续效果有限。 目的与方法：本研究在BICOV-1试验中探讨了HIPEC联合术后NIPEC-LT的治疗方案，该试验是一项前瞻性、非随机化的I期研究，旨在评估其可行性、安全性和肿瘤学结果。主要目标是评估治疗完成率和并发症发生率。次要终点包括无病生存期（DFS）、总生存期（OS）和生活质量指标。HIPEC与NIPEC-LT联合是一种合理的策略，因为两者均显示出独立的益处且毒性不重叠。HIPEC诱导的生物学变化可能增强后续腹腔化疗的疗效。该试验将为未来评估强化腹腔内治疗在卵巢癌管理中作用的II/III期研究提供关键数据。
肿瘤(癌症)患者之家