A phase II, single-arm, open-label clinical trial to evaluate the combination of cadonilimab injection and gut microbiota modulation in the treatment of persistent, recurrent, or metastatic cervical cancer following second-line therapy
Abstract
TPS5622
Background:
Current treatment options for cervical cancer include surgery, radiotherapy, and chemotherapy. For persistent, recurrent, or metastatic disease, systemic therapies such as targeted agents and immune checkpoint inhibitors (ICIs) play a crucial role. The NCCN 2023.V1 guidelines recommend PD-1/CTLA-4 bispecific antibody Cadonilimab as a second-line option for recurrent or metastatic cervical cancer. In April 2024, China’s NMPA accepted an application for Cadonilimab plus platinum-based chemotherapy (± bevacizumab) as second-line treatment, based on the global phase III AK104-303 trial. Cadonilimab monotherapy demonstrated a 33.0% objective response rate (ORR) and a 12% complete response rate (CR) in platinum-resistant cervical cancer, with an ORR of 43.8% in PD-L1+ patients. Recent research highlights the gut microbiome as a key modulator of immunity and ICI responses across multiple cancers. Gut microbiota modulation may enhance antitumor immunity, improve ICI efficacy, and reduce immune-related adverse events. Fecal microbiota transplantation (FMT) has been shown to restore immune homeostasis by increasing short-chain fatty acid (SCFA) production, particularly butyrate, which strengthens the intestinal barrier and suppresses inflammation. Despite promising findings in other malignancies, no clinical studies have assessed the impact of gut microbiota modulation in advanced cervical cancer immunotherapy. Further investigations are needed to evaluate its…
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