Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Chemotherapy-eclipse for Locally Advanced Cervical Cancer：A Single-arm, Open-label, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR)
研究概览
简要总结
Locally advanced cervical cancer (LACC) remains a significant global health concern with limited treatment options. Recent advancements suggest that using neoadjuvant anti-PD-1 inhibitors in combination with chemotherapy, followed by radical surgery, may be an effective treatment strategy for patients with PD-L1-positive LACC. This study aims to evaluate the efficacy and safety of preoperative treatment with iparomlimab and tuvonralimab-a bifunctional PD-1/CTLA-4 dual blocker-combined with chemotherapy for LACC.
详细描述
A total of 43 patients with FIGO 2018 stages IB3, IIA2, IIB, or IIIC1r will receive a combination treatment consisting of iparomlimab and tuvonralimab (5 mg/kg administered intravenously), cisplatin (75-80 mg/m², intravenously), and nab-paclitaxel (260 mg/m², intravenously) for one cycle. Following this, patients will receive two additional cycles of iparomlimab and tuvonralimab at the same dosage of 5 mg/kg, administered at three-week intervals. After completing three cycles of neoadjuvant treatment, patients who show a complete response (CR) or partial response (PR) will undergo radical surgery. The decision regarding subsequent adjuvant therapy will be guided by the NCCN guidelines. In contrast, patients with stable or progressive disease will proceed to concurrent chemoradiotherapy (CCRT).
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
- •1、Written informed consent
- •2、18-70 years old
- •3、Adequate organ function and ECOG of 0 ~1
- •4、Without systemic therapy at the time of enrollment
- •5、FIGO 2018 stage IB3, IIA2, or IIIC1r
- •6、Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- •7、Measurable lesions could be defined by RECIST v1.1
- •8、Willing to get blood/ tumor tissue tested
- •9、Patients who observed the rules about the scheduled visit, study schedule, and medical examination
- •10、The function of major organs is normal, and the following criteria are met:
- •10.1 Blood routine examination must meet: (no blood transfusion within 14 days)
- •ANC≥1.5x10^9/L; PLT≥100x10^9/L;
- •10.2 The biochemical examination must meet the following standards BIL < 1.5 × ULN; ALT and AST < 2.5xULN; ALB≥ 28 g/L
- •11、Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures.
排除标准
- •1、History of other malignancies within 3 years
- •2、Participate in other clinical trials at the same time
- •3、Active autoimmune disease, which needs systemic therapy
- •4、Uncontrolled infection, which needs systemic therapy
- •5、History of allogeneic tissue/solid organ transplant
- •6、Serious illness, such as severe mental disorders, cardiac disease, coagulation disorders, digestive system disease, etc
- •7、Active HBV, HCV, or HIV infection
- •8、Pregnant or lactating female patients
- •9、Drug or alcohol abuse
- •10、 Unable or unwilling to sign the informed consent
研究组 & 干预措施
Study group : iparomlimab and tuvonralimab plus nab-paclitaxel, cisplatin
Participants will receive iparomlimab and tuvonralimab at a dose of 5 mg/kg, nab-paclitaxel at 260 mg/m², and cisplatin at 75-80 mg/m², all administered intravenously on day 1. After three weeks, participants will continue with only iparomlimab and tuvonralimab(5 mg/kg) for two additional cycles at an interval of 3 weeks.
干预措施: neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles (Drug)
结局指标
主要结局
Pathological complete response (pCR)
时间窗: From enrollment to the end of surgery at 3 months
Pathological complete response（pCR） is defined as the absence of viable tumor cells by surgery
Pathological complete response (pCR)
时间窗: From enrollment to the end of surgery at 3 months
Pathological complete response（pCR） is defined as the absence of viable tumor cells by surgery
次要结局
- Adverse events(During the treatment（12months）)
- Objective response rate (ORR)(From enrollment to the end of surgery at 3 months)
- Event-free survival (EFS)(Through the study completion, an average of 2 year)
- Primary pathological response (MPR)(From enrollment to the end of surgery at 3 months)
- Disease-free survival (DFS)(Through the study completion, an average of 2 year)
- Adverse events(During the treatment（12months）)
- Objective response rate (ORR)(From enrollment to the end of surgery at 3 months)
- Event-free survival (EFS)(Through the study completion, an average of 2 year)
- Primary pathological response (MPR)(From enrollment to the end of surgery at 3 months)
- Disease-free survival (DFS)(Through the study completion, an average of 2 year)