RecruitingPhase 2NCT05687851

Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer

A Single-arm, Multicenter, Phase II Study to Evaluate Cadonilimab(AK104) Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer


Sponsor

Chongqing University Cancer Hospital

Enrollment

33 participants

Start Date

Dec 29, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Cadonilimab(AK104)is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4. This is a single-arm, multicenter, open-label, phase II study, the purpose of this study is to evaluate the efficacy and safety of Cadonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining an immunotherapy drug called cadonilimab with radiation therapy can effectively treat women with locally advanced cervical cancer who cannot tolerate standard chemotherapy alongside radiation. **You may be eligible if...** - You are a woman aged 18 or older - You have locally advanced cervical cancer confirmed by biopsy (squamous cell, adenocarcinoma, or adenosquamous type) - Your cancer is at FIGO stage IB3, IIA2, IIB, or up to IVA (advanced but not yet spread to distant organs) - You are unable to tolerate standard chemotherapy - You have at least one measurable tumor on imaging - You are in reasonable health (ECOG 0–2) with a life expectancy of at least 12 weeks **You may NOT be eligible if...** - Your cervical cancer has spread to distant organs (stage IVB) - You have already had a total hysterectomy - Your cancer is a rare type (e.g., neuroendocrine or small cell) - You have received prior systemic treatment for cervical cancer - You are pregnant 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

DRUGCadonilimab(AK104)

q3w iv

RADIATIONEBRT

45-50.4Gy

RADIATIONBT

≥80Gy


Locations(1)

Chongqing university Cancer Hospital

Chongqing, CHN, China

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NCT05687851


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