Combining Disitamab Vedotin with Cisplatin for Cervical Cancer Treatment
Disitamab Vedotin Combined With Cisplatin for Neoadjuvant Therapy in Locally Advanced Cervical Cancer: a Prospective, Single-arm Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Drugs / interventions | Disitamab, chemotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06558682 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with cervical squamous cell carcinoma who are HER2 positive.
Not a fit: Patients with cervical adenocarcinoma will not benefit from this study.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of cervical squamous cell carcinoma * HER-2 positive Exclusion Criteria: * Cervical adenocarcinoma
Where this trial is running
Jinan, Shandong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.