A Prospective, Single Arm, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Concurrent Chemoradiotherapy Followed by Cadonilimab(AK104) for Newly Diagnosed Local Advanced Cervical Cancer
This study will evaluate the efficacy and safety of concurrent chemoradiotherapy(CCRT)followed by cadonilimab(AK104) in high risk local advanced cervical cancer. Participants received CCRT,efficacy evaluation of CCRT was no disease progression who maintained with AK104(10.0 mg/kg,Q3W)until drug exposure over 1 years or disease progression or intolerable toxicity.
• Voluntary agreement to provide written informed consent.
• female, Age 18 -75 years.
• Predicted survival ≥ 3 month.
• Histologically and/or cytologically confirmed Squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, FIGO 2018 stage III-IVA.
• Unable to undergo curative surgery,Pior not received systemic therapy before CCRT, Including but not limited to radiotherapy, chemotherapy, immunotherapy, and biological therapy,etc.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Have at least one evaluable lesion (RECIST 1.1 criteria)
• Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment.
• participants are eligible to participate if they agree to the contraception use as per study protocol.
• Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.