RecruitingPhase 2NCT05511623

Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer

Efficacy and Safety of Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer


Sponsor

First Affiliated Hospital of Guangxi Medical University

Enrollment

112 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug called tislelizumab to standard chemotherapy and radiation treatment improves outcomes for women with stage IIIC2 cervical cancer — an advanced stage where the cancer has spread to lymph nodes near the aorta (the body's main artery). **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with stage IIIC2 cervical cancer confirmed by biopsy (squamous cell, adenocarcinoma, or adenosquamous type) - Your cancer has not spread to distant organs - You are in good general health (ECOG score 0–1) - Your blood counts and organ function meet the required levels - You are post-menopausal or using reliable contraception if of childbearing age **You may NOT be eligible if...** - Your cancer has spread beyond the pelvis to distant organs - You have received prior treatment for cervical cancer - You have an autoimmune disease or are taking immune-suppressing drugs - You are pregnant or breastfeeding - You have severe heart, liver, or kidney problems 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

DRUGtislelizumab

standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks, combined with tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year.

OTHERconcurrent chemoradiotherapy

standard radiotherapy with concomitant cisplatin 40mg/m2 on day 1 once every week for 5 weeks.


Locations(1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

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NCT05511623


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