Study of CRP Changes During Immunotherapy in Women with Advanced or Metastatic Gynecological Cancers

What this Trial Is About

Researchers are investigating how changes in C-reactive protein CRP, an inflammatory marker, relate to outcomes in women with advanced or metastatic gynecological cancers receiving immunotherapy. This observational study focuses on the value of CRP levels during immune checkpoint inhibitor ICI treatment, aiming to understand how CRP changes predict response rates, progression-free survival, and overall survival. Immunotherapy is already part of standard care for these cancers, and this study builds on findings from other cancers where mild inflammation indicates better treatment effect. Participants will be observed under two groups those receiving chemotherapy alone and those receiving chemotherapy combined with immunotherapy. The study tracks CRP levels through blood samples during and after the therapy. It includes women with metastatic gynecological cancers who are starting either ICI therapy with chemotherapy or chemotherapy without ICI, depending on treatment plans. The study is prospective and multicenter, with follow-up planned over 10 years. During the study, participants will provide regular blood samples for CRP measurement alongside their usual care. Researchers will monitor how CRP changes relate to disease progression and treatment response. They will evaluate outcomes such as progression-free survival, objective response rate, and overall survival over a long-term follow-up. Consent and eligibility screening occur before enrollment, and participants health and treatment status will be recorded throughout the study period.

Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies