Disitamab Vedotin Combined With Cisplatin for Neoadjuvant Therapy in Locally Advanced Cervical Cancer: a Prospective, Single-arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- pathologic complete remission
研究概览
简要总结
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.
详细描述
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:
- To evaluate the safety of Disitamab Vedotin combined with cisplatin;
- To evaluate the effects of Disitamab Vedotin combined with cisplatin on surgical complications, surgical clearance rate and postoperative adjuvant treatment ratio;
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of cervical squamous cell carcinoma
- •HER-2 positive
排除标准
- •Cervical adenocarcinoma
研究组 & 干预措施
Disitamab Vedotin Combined with Cisplatin
Locally advanced cervical cancer patient was treated with Disitamab Vedotin combined with Cisplatin for neoadjuvant therapy.
干预措施: Disitamab Vedotin and Cisplatin (Drug)
结局指标
主要结局
pathologic complete remission
时间窗: At the end of Cycle 3 (each cycle is 21 days)
The rate of patients with pathological examination revealed an absence of malignant cells.
次要结局
- Objective Response Rate(At the end of Cycle 3 (each cycle is 21 days))
研究者
Kun Song
Chief Physician
Qilu Hospital of Shandong University