Effect of Sodium Thiosulfate on Nephrotoxicity of Cisplatin Intraperitoneal Heat-perfusion Chemotherapy
Status:
Not yet recruiting
Trial end date:
2025-04-01
Target enrollment:
Participant gender:
Summary
Ovarian cancer is the most lethal malignancy of the female genital tract. Cytoreductive
surgery combined with chemotherapy is the primary treatment for ovarian cancer, and radical
tumor resection is an important means to improve the prognosis. However, even after complete
tumor resection, 75% of patients with ovarian cancer still recur within 3 years after the
initial treatment and eventually die from recurrence. In ovarian cancer, the lesions are
located primarily in the peritoneal cavity. High-grade evidence demonstrates that the use of
intraperitoneal hyperthermic chemotherapy (HIPEC) with cisplatin after cytoreductive surgery
significantly improves the outcome in some patients with ovarian cancer. Currently, this is
the only non-pharmacologic treatment that reduces both the risk of recurrence and death from
ovarian cancer with a multi treatment. However, HIPEC with cisplatin can lead to acute kidney
injury, and a serious complication that can seriously affect the short and long-term
prognosis of patients. Sodium thiosulfate has previously been reported to reduce the
incidence of acute kidney injury after HIPEC with cisplatin, but this finding has not been
confirmed in a high-level study. Therefore, we propose a multi-center, prospective,
open-label, randomized, controlled trial including 110 patients with ovarian cancer who
received HIPEC with cisplatin, to evaluate whether sodium thiosulfate combined with hydration
(55 patients in the trial group) can reduce the incidence of acute kidney injury after HIPEC
with cisplatin compared with hydration alone (55 patients in the control group), and to
provide high-level evidence for the rationale of using sodium thiosulfate for nephrotoxicity
relief in cisplatin HIPEC.
Phase:
Phase 2
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators:
Qilu Hospital of Shandong University Yunnan Cancer Hospital