| NCT ID | NCT06558682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Uterine Cervical Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-10-20 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2024-10-20 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Clinical diagnosis of cervical squamous cell carcinoma * HER-2 positive Exclusion Criteria: * Cervical adenocarcinoma
Contact & Investigator
Kun Song
PRINCIPAL INVESTIGATOR
Qilu Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT06558682 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Uterine Cervical Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06558682 currently recruiting?
Yes, NCT06558682 is actively recruiting participants. Contact the research team at buhualei@email.sdu.edu.cn for enrollment information.
Where is the NCT06558682 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06558682 clinical trial?
NCT06558682 is sponsored by Qilu Hospital of Shandong University. The principal investigator is Kun Song at Qilu Hospital of Shandong University. The trial plans to enroll 48 participants.