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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
West China Second University Hospital
RECRUITING
Chengdu
Contact Information
Primary
Rutie Yin, Clinical Professor
yrtt2013@163.com
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 50
Treatments
Experimental: treatment group
AK104(10.0 mg/kg,intravenous (IV) infusion,Q3W) after CCRT
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Hospital Of Southwest Medical University, Affiliated Hospital of North Sichuan Medical College
Leads: West China Second University Hospital

This content was sourced from clinicaltrials.gov