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Trial Title:
Neoadjuvant Therapy in Cervical Cancer
NCT ID:
NCT06558682
Condition:
Uterine Cervical Neoplasms
Conditions: Official terms:
Uterine Cervical Neoplasms
Disitamab vedotin
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamab Vedotin and Cisplatin
Description:
Disitamab Vedotin: 2mg/Kg,ivdrip, 3 weeks/cycle,3 cycles. Cisplatin: 75-80mg/m2, ivdrip,
3 weeks/cycle,3 cycles.
Arm group label:
Disitamab Vedotin Combined with Cisplatin
Other name:
Aidixi
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Clinical diagnosis of cervical squamous cell carcinoma
- HER-2 positive
Exclusion Criteria:
- Cervical adenocarcinoma
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
October 20, 2024
Completion date:
October 1, 2026
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
RemeGen Co., Ltd.
Agency class:
Industry
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06558682
