A Phase II Study of Candonilimab (AK104) Combined With Preoperative Chemotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- pCR
研究概览
简要总结
This is a prospective, single-arm, open-label，multi-center, phase II study, aiming to evaluate the efficacy and safety of AK104 combined with preoperative chemotherapy in patients with locally advanced ESCC.
详细描述
Eligible patients first receive AK104 (10mg/kg, iv, Q2W) for one cycle in the induction period, and then patients receive AK104 (10mg/kg, iv, Q3W) combined with nab-paclitaxel (130mg/m2 ivgtt d1，d8, Q3W) and carboplatin ((AUC=5) d1，Q3W) for 2 cycles. After neoadjuvant therapy of 3 cycles, patient will undergo preoperative evaluation. For patients who can be performed for R0 surgery, surgery wil be performed in 4 to 6 weeks. Patients who do not achieve Pathological complete response (pCR) will receive AK104 (10mg/kg, iv, Q3W) as adjuvant therapy until disease progression or intolerable toxicity for up to 12 months. Patients who achieve pCR after surgery will be enrolled in observational follow-up.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signing a written informed consent form;
- •Males or females aged ≥ 18 to ≤ 70 years;
- •ECOG score 0-1;
- •Pathologically diagnosed thoracic esophageal squamous cell carcinoma;
- •No distant metastasis after imaging examination, and esophageal cancer can be resected or potentially resectable with stage cT1b-cT2N+M0 or cT3-cT4a anyN M0 or cT2N0M0 high-risk (lymphovascular invasion or tumor ≥3 cm or hypo-differentiation) (AJCC 8th edition cTNM stage);
- •Not received prior antitumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, etc. for esophageal cancer);
- •Life expectancy is greater than 6 months;
- •At least one measurable tumor lesion per RECIST v1.1;
- •Major organ functions are adequate;
排除标准
- •Patient has received previous antitumor therapy (chemotherapy, radiation, surgery or immunotherapy);
- •Cervical or thoracic esophageal cancer is < 5 cm from the cricopharyngeal muscle;
- •Patients are or are expected to be at significant risk of esophageal perforation, fistula, and major bleeding;
- •Imaging during the screening period showed that the tumor surrounded or invaded important blood vessels or organs (such as the heart and pericardium, trachea, aorta, superior vena cava, etc.) or there was obvious necrosis or cavity, and the investigator determined that entering the study would cause bleeding risk; participants at risk of developing oesophageal or oesophageal fistula;
- •Patients with a history of other malignant diseases in the last 5 years，unless complete resolution or no additional treatment is required (exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervix, or breast carcinoma in situ)；
- •Pregnant or nursing women；
- •Patients with known or suspected active autoimmune disease;
- •Patients with a history of myocarditis, cardiomyopathy, malignant arrhythmias;
- •Other patients are not eligible for enrollment assessed by investigators;
研究组 & 干预措施
AK104 plus nab-paclitaxel and carboplatin
In the induction period, AK104 (10mg/kg, iv, Q2W) is given for one cycle;
and then AK104 (10mg/kg, iv, Q3W) is combined with nab-paclitaxel (130mg/m2 ivgtt d1，d8, Q3W) and carboplatin ((AUC=5) d1，Q3W) for 2 cycles;
After R0 surgery, AK104 (10mg/kg, iv, Q3W) is given as adjuvant therapy for up to 12 months for those who do not achieve pCR.
干预措施: AK104, nab-paclitaxel, carboplatin (Drug)
结局指标
主要结局
pCR
时间窗: up to 2 years
Pathological complete response
次要结局
- MPR(up to 2 years)
- OS(up to 2 years)
- R0 resection rate(up to 2 years)
- DFS(up to 2 years)
- Downstaging rate(up to 2 years)
- AE(up to 2 years)
研究者
Feng Wang
Medical Oncology
The First Affiliated Hospital of Zhengzhou University