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RECRUITING
NCT06558682
NA

Neoadjuvant Therapy in Cervical Cancer

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-10-20

Completion Date

2026-10-01

Last Updated

2025-04-01

Healthy Volunteers

No

Interventions

DRUG

Disitamab 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