Neoadjuvant Therapy in Cervical Cancer

Not Applicable

Recruiting

• Conditions: Uterine Cervical Neoplasms
• Interventions: Drug: Disitamab Vedotin and Cisplatin

• Registration Number: NCT06558682
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Primary research objectives:

To evaluate the effect of Disitamab Vedotin combined with cisplatin on pathological response rate (pCR) of locally advanced cervical cancer.

Secondary research objectives:

1. To evaluate the safety of Disitamab Vedotin combined with cisplatin;

2. To evaluate the effects of Disitamab Vedotin combined with cisplatin on surgical complications, surgical clearance rate and postoperative adjuvant treatment ratio;

3. To evaluate the effects of Disitamab Vedotin combined with cisplatin on objective tumor response rate (ORR), disease control rate (DCR) and survival;

Exploratory research objectives:

To explore the changes of tumor tissue protein expression, immune factors and HER-2 receptor expression before and after the use of ADC drugs, as well as biomarkers that can effectively predict the therapeutic effect.

Study Timeline

• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-19
• Study Start: 2024-10-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

• Cervical adenocarcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Disitamab Vedotin Combined with Cisplatin	Disitamab Vedotin and Cisplatin	Locally advanced cervical cancer patient was treated with Disitamab Vedotin combined with Cisplatin for neoadjuvant therapy.

Primary Outcome Measures

Name	Time	Method
pathologic complete remission	At the end of Cycle 3 (each cycle is 21 days)	The rate of patients with pathological examination revealed an absence of malignant cells.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	At the end of Cycle 3 (each cycle is 21 days)	the proportion of patients whose tumor volume has shrunk to a predetermined value and maintains the minimum time frame required

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China