RecruitingPhase 2NCT06251388

A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab(AK104) for Newly Diagnosed Local Advanced Cervical Cancer

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


Sponsor

West China Second University Hospital

Enrollment

50 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug called cadonilimab (AK104) to standard chemoradiation (chemotherapy plus radiation) improves outcomes for women with locally advanced cervical cancer (stage III–IVA) who cannot have surgery. The treatment combines radiation, chemotherapy, and immune checkpoint blockade. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have confirmed cervical cancer (squamous cell, adenocarcinoma, or adenosquamous) at stage III or IVA - Your cancer cannot be surgically removed - You have not received any prior treatment for this cancer - You are in good physical condition (ECOG 0 or 1) - You have adequate organ function **You may NOT be eligible if...** - You have cancer that has spread beyond the pelvis (distant metastases) - You have received prior chemotherapy, radiation, or immunotherapy for this cancer - You have active autoimmune disease or are taking immune-suppressing medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK104

AK104(10.0 mg/kg,intravenous (IV) infusion,Q3W)maintained with no more than 1 year.


Locations(1)

West China Second University Hospital

Chengdu, Sichuan, China

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NCT06251388


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