RecruitingNot ApplicableNCT06558682

Neoadjuvant Therapy in Cervical Cancer

Disitamab Vedotin Combined With Cisplatin for Neoadjuvant Therapy in Locally Advanced Cervical Cancer: a Prospective, Single-arm Clinical Trial


Sponsor

Qilu Hospital of Shandong University

Enrollment

48 participants

Start Date

Oct 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In the comprehensive dataset of clinical diagnoses and treatments for cervical cancer in China, 49.8% of patients with stage IB3 and IIA2 receive surgical intervention following neoadjuvant chemotherapy. This indicates a pressing need to optimize neoadjuvant chemotherapy regimens for locally advanced cervical cancer. While paclitaxel combined with cisplatin is the conventional approach, 9.8% to 30.6% of patients demonstrate suboptimal responses, with a pathological complete response rate of approximately 10%. Currently, the efficacy of antibody-drug conjugates in neoadjuvant chemotherapy for cervical cancer remains unexplored. This study seeks to address this gap by evaluating the combination of Disitamab Vedotin and Cisplatin in patients with stage IB3 and IIA2 cervical cancer with positive HER2 expression.The study will assess the impact of this regimen on pathological complete response rates, surgical complications, surgical resection rates, and overall survival.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating neoadjuvant therapy — treatment given before surgery — for patients with cervical cancer that has a specific molecular marker called HER-2 positive. HER-2 is a protein found on some cancer cells that can be targeted by certain drugs. This study aims to see whether targeting HER-2 before surgery improves outcomes for this subgroup of cervical cancer patients. **You may be eligible if...** - You have a confirmed clinical diagnosis of cervical squamous cell carcinoma (a specific cell type of cervical cancer) - Your tumor has tested positive for HER-2 (a protein marker on cancer cells) - You have not yet undergone surgery for your cervical cancer **You may NOT be eligible if...** - Your cervical cancer is a different cell type called adenocarcinoma (originating from glandular cells rather than squamous cells) - You have already received treatment for your cervical cancer 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

DRUGDisitamab Vedotin and Cisplatin

Disitamab Vedotin: 2mg/Kg,ivdrip, 3 weeks/cycle,3 cycles. Cisplatin: 75-80mg/m2, ivdrip, 3 weeks/cycle,3 cycles.


Locations(1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT06558682


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