RecruitingPhase 3NCT05173272

Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer

A Prospective Randomized Controlled Trials of Neoadjuvant Chemotherapy Combined With Serplulimab Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer


Sponsor

Sichuan Cancer Hospital and Research Institute

Enrollment

286 participants

Start Date

Jul 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective of this study is to determine whether neoadjuvant chemotherapy combined with slulimumab sequential concurrent chemoradiotherapy versus concurrent chemoradiotherapy for locally advanced cervical cancer could improve progression-free survival rates. Women in the experimental arm will receive neoadjuvant chemotherapy (cisplatin plus paclitaxel) combined with slulimumab every 21 days during 2 cycles followed by concurrent chemoradiation therapy. Women in the control arm will receive concurrent chemoradiation therapy alone. 286 patients will be recruited during 2 years, with 3 years of follow up period.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding immunotherapy to chemotherapy before and during radiation therapy improves outcomes for women with advanced cervical cancer that cannot be treated with surgery alone. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with advanced cervical cancer (stage Ib3 to IIIc2) confirmed by biopsy - You have not yet received any treatment for this cancer - You are in good general health (ECOG performance score 0–1) - Your blood counts, liver, and kidney function are within acceptable ranges - Your heart is functioning adequately - You are willing to use contraception during the study **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have another active cancer (except certain early-stage skin cancers) - You have bone marrow or blood disorders - You have active HIV, hepatitis, or other serious infections - You have had prior pelvic radiation 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

DRUGNeoadjuvant Therapy

Cisplatin 50 mg/m\^2 d1 q21+ Paclitaxel 175 mg/m\^2 d1 q21+serplulimab 300mg d1 q21

RADIATIONCCRT

weekly cisplatin for 4 or 5 weeks is administered concomitant with EBRT (45-50.4Gy) in 1.8-2 daily fractions and a 10-20 Gy boost to reach a total dose of 65 Gy when there was unresectable lymph nodes.

RADIATIONBrachytherapy

The primary cervical tumor is the boosted, using image guided 3D brachytherapy or 2D brachytherapy, with an additional 30-40 Gy to HRCTV (3D brachytherapy) or to point A (2D brachytherapy), to achieve a total dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors.


Locations(1)

Sicchuan cancer hospital

Chengdu, Sichuan, China

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NCT05173272


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