Study of Tinzaparin Injections During Chemotherapy for Advanced Ovarian Cancer

What this Trial Is About

Researchers are evaluating the potential antitumor effects of tinzaparin, a commonly used anticoagulant, in women with advanced epithelial ovarian cancer EOC who are receiving neoadjuvant chemotherapy NACT. This pilot Phase II clinical trial aims primarily to assess how tinzaparin affects the levels of the tumor marker CA-125 during treatment. The study also explores how tinzaparin influences various immune and coagulation factors, and monitors compliance and side effects related to its use. Participants are randomly assigned to either receive daily subcutaneous injections of tinzaparin dose based on weight alongside standard chemotherapy with carboplatin and paclitaxel or to receive chemotherapy alone without tinzaparin. The treatment period spans 21 to 28 weeks, starting with chemotherapy and continuing through delayed primary debulking surgery DPDS and postoperative care. Blood samples for biomarker analysis are collected at multiple time points, including before each chemotherapy cycle, pre- and post-surgery, and after the last chemotherapy session. Patients in the tinzaparin group may choose to continue the anticoagulant following surgery and initial chemotherapy cycles. Throughout the study, women undergo clinical evaluations and imaging to guide surgery decisions. Researchers collect blood to measure markers such as hemoglobin, platelets, leucocytes, C-reactive protein, albumin, CA-125, and several coagulation and inflammation-related proteins. Compliance with tinzaparin injections and any treatment-related adverse events are closely monitored. The total participation time ranges from 22 to 29 weeks, covering chemotherapy, surgery, and follow-up periods.

Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer