Neoadjuvant Therapy in Cervical Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorQilu Hospital of Shandong University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of cervical squamous cell carcinoma

HER-2 positive

Disqualifiers

Cervical adenocarcinoma

Trial design

Design model

Single group

Treatments tested in this trial

  • Disitamab Vedotin and Cisplatin

    Drug

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

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Disitamab Vedotin Combined with CisplatinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pathologic complete remission

The rate of patients with pathological examination revealed an absence of malignant cells.

Time frame
At the end of Cycle 3 (each cycle is 21 days)

Secondary outcomes

1

Objective Response Rate

the proportion of patients whose tumor volume has shrunk to a predetermined value and maintains the minimum time frame required

Time frame
At the end of Cycle 3 (each cycle is 21 days)

Other outcomes

Sponsors and contacts

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