RecruitingPhase 2NCT05311566

PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer

Effectiveness and Safety of Camrelizumab Combined With Concurrent Chemoradiotherapy for FIGO IB2-IIIB Cervical Cancer: A Single-center, Single-arm, Open-phase II Clinical Study


Sponsor

Lei Li

Enrollment

92 participants

Start Date

Mar 27, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-center, single-arm, open-phase II clinical study, the main purpose of which is to evaluate the effectiveness and safety of camrelizumab combined with concurrent chemoradiotherapy for early and locally advanced cervical cancer, i.e., FIGO 2018 IB2-IIIB cervical cancer. Eligible subjects will be given cisplatin and radiotherapy, for 6-8 weeks, camrelizumab repeated every 14 days until disease progression, toxicity intolerance, or other reasons specified in the protocol. Subjects who finished treatment entered the safety follow-up or survival follow-up.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a PD-1 immunotherapy drug to the standard chemoradiation treatment improves outcomes for women with locally advanced cervical cancer (stages IB2–IIIB). PD-1 inhibitors help the immune system recognize and attack cancer cells. **You may be eligible if...** - You are a woman aged 18 or older with cervical cancer confirmed by biopsy (squamous cell, adenocarcinoma, or adenosquamous type, stages IB2–IIIB) - You have not received any prior treatment for cervical cancer (no radiation, chemotherapy, or other systemic therapy) - You have measurable tumor lesions - Your general health is good enough for treatment (ECOG 0–2) - Your expected survival is greater than 6 months - Women of childbearing age agree to use contraception during and for 6 months after treatment **You may NOT be eligible if...** - You have severe organ dysfunction or lab values outside the protocol range - You are pregnant or unable to comply with study requirements 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

COMBINATION_PRODUCTCamrelizumab plus Concurrent chemoradiotherapy

Participants will be given intravenous administration of Camrelizumab (200mg,every 2 weeks),Cisplatin(40mg/m²,everyweek) and Radiotherapy. After completing 6\~8weeks of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until disease progression or unacceptable toxicity.


Locations(1)

Lei Li

Beijing, Beijing Municipality, China

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NCT05311566


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