Combining Disitamab Vedotin with Cisplatin for Cervical Cancer Treatment
Official title: Disitamab Vedotin Combined With Cisplatin for Neoadjuvant Therapy in Locally Advanced Cervical Cancer: a Prospective, Single-arm Clinical Trial
Run by Qilu Hospital of Shandong University · NCT06558682 · Data updated 2026-11-12
This study is testing if a new combination of Disitamab Vedotin and cisplatin can help patients with advanced cervical cancer feel better and improve their chances of successful surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 48 (estimated) |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Drugs / interventions | Disitamab, chemotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | October 20, 2024 |
| Main results expected | October 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | April 1, 2025 |
| Trial ID | NCT06558682 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with cervical squamous cell carcinoma who are HER2 positive.
✕Probably not a fit
Patients with cervical adenocarcinoma will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of Disitamab Vedotin combined with cisplatin as a neoadjuvant chemotherapy regimen for patients with locally advanced cervical cancer, specifically those with stage IB3 and IIA2 and positive HER2 expression. The primary objective is to assess the pathological complete response rate, while secondary objectives include evaluating safety, surgical outcomes, and overall survival. The study also aims to explore changes in tumor tissue protein expression and potential biomarkers for predicting treatment response.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with locally advanced cervical cancer.
How similar studies have gone: While the efficacy of antibody-drug conjugates in neoadjuvant chemotherapy for cervical cancer is largely unexplored, similar approaches in other cancers have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of cervical squamous cell carcinoma * HER-2 positive Exclusion Criteria: * Cervical adenocarcinoma
Where it's running
-
Qilu Hospital of Shandong University
Jinan, Shandong, China Recruiting
Study contacts
- Principal investigator: Kun Song — Qilu Hospital of Shandong University
- Study coordinator: Hualei Bu
- Email: buhualei@email.sdu.edu.cn
- Phone: 86-0531-82169269
Similar studies
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This study tests a combo of a PD1/CTLA4 bispecific antibody with standard chemotherapy to see if it can improve outcomes before surgery in women with locally advanced cervical cancer.
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Disitamab Vedotin Plus Radiotherapy for HER2-Expressing Upper Tract Urothelial Carcinoma After Surgery
This study tests whether disitamab vedotin with radiotherapy can improve outcomes for people with HER2-expressing upper tract urothelial carcinoma after radical surgery who can’t receive cisplatin.
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Disitamab vedotin plus SOX versus SOX alone as adjuvant treatment for HER2-moderate/high stage III gastric cancer after surgery
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.