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NCT06558682Recruiting

Neoadjuvant Therapy in Cervical Cancer

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

Source: ClinicalTrials.gov · Last updated 1 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
48 (estimated)
First submitted
12 Aug 2024
Start date
20 Oct 2024
Primary completion date
1 Oct 2026
Lead sponsor
Qilu Hospital of Shandong University
NCT number
NCT06558682

What you commit to

  • Study type: Interventional
  • Planned participants: 48
  • From 20 Oct 2024 to the primary completion date, 1 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Cervical adenocarcinoma

Who the study is looking for

  • Clinical diagnosis of cervical squamous cell carcinoma
  • HER-2 positive

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Qilu Hospital of Shandong University
Coordinator of this site? Confirm its status
JinanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.