Phase 2 Study of Cadonilimab Plus Cisplatin Chemotherapy Before Surgery for Locally Advanced Cervical Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Cadonilimab combined with chemotherapy cisplatin for treating locally advanced cervical cancer. This is a multicenter, single-arm, Phase 2 trial involving 29 patients diagnosed with cervical cancer at stages IB3, IIA2, IIB, and IIIC. The study aims to explore how Cadonilimab and cisplatin work together before surgery and to examine markers like PD-L1 expression and tumor mutational burden related to treatment response. Participants receive Cadonilimab at a dose of 10 mgkg intravenously on day 1 every 3 weeks, along with cisplatin at 75 mgm intravenously on day 2 every 3 weeks. This treatment continues for 2 to 4 cycles before patients undergo radical surgery to remove the cancer. After surgery, doctors decide on additional therapy as needed, starting approximately 6 weeks later but no later than 3 months post-surgery. Imaging scans are done every three months after surgery to check for cancer recurrence. Throughout the study, patients have regular safety visits from the first medication dose until 60 days after the last dose or until they start new cancer treatment. Researchers monitor treatment response, including pathological complete response and radiological response rates, and follow patients for up to 5 years to assess long-term outcomes. Survival and safety are tracked every three months after any disease recurrence.

Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer