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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Clinical diagnosis of cervical squamous cell carcinoma

• HER-2 positive

Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Hualei Bu
buhualei@email.sdu.edu.cn
86-0531-82169269
Time Frame
Start Date: 2024-10-20
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 48
Treatments
Experimental: Disitamab Vedotin Combined with Cisplatin
Locally advanced cervical cancer patient was treated with Disitamab Vedotin combined with Cisplatin for neoadjuvant therapy.
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University
Collaborators: RemeGen Co., Ltd.

This content was sourced from clinicaltrials.gov