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Neoadjuvant Therapy in Cervical Cancer

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06558682
Enrollment
48
Registered
2024-08-19
Start date
2024-10-20
Completion date
2026-10-01
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Neoplasms

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.

Interventions

DRUGDisitamab Vedotin and Cisplatin

Disitamab Vedotin: 2mg/Kg,ivdrip, 3 weeks/cycle,3 cycles. Cisplatin: 75-80mg/m2, ivdrip, 3 weeks/cycle,3 cycles.

Sponsors

RemeGen Co., Ltd.
CollaboratorINDUSTRY
Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Cervical adenocarcinoma

Design outcomes

Primary

MeasureTime frameDescription
pathologic complete remissionAt the end of Cycle 3 (each cycle is 21 days)The rate of patients with pathological examination revealed an absence of malignant cells.

Secondary

MeasureTime frameDescription
Objective Response RateAt 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

Countries

China

Contacts

Primary ContactHualei Bu
buhualei@email.sdu.edu.cn86-0531-82169269

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026