Efficacy and Safety of Inductive Chemoimmunotherapy Followed by Chemoradiotherapy With or Without Surgery in Locally Advanced Esophageal Squamous Cell Cancer: a Single-arm, Prospective, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Event-free survival
研究概览
简要总结
Although unprecedented advances have been made in the field of esophageal cancer in recent decades, the prognosis for patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains extremely poor, accounting for 30-40% of overall survival at 5 year. In recent years, multimodal treatments have proven to be an appropriate therapeutic approach for locally advanced ESCC. Recently, immunotherapy developed rapidly. The purpose of this study was to observe the efficacy and safety of cardonilizumab combined with chemoradiotherapy in the treatment of locally advanced ESCC.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old；
- •Eligible patients were histologically confirmed esophageal squamous cell carcinoma;
- •Eligible patients were proven locally advanced ESCC (cT1-2N1-3M0-1, cT3/T4N0-3M0-1, M1 was limited to supraclavicular lymph node metastasis）diagnosed by computed tomography [CT] and/or endoscopic ultrasonography [EUS] according to the American Joint Committee on Cancer (AJCC) 8th edition staging system；
- •ECOG PS score: 0~1；
- •Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;
排除标准
- •Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- •patients who had previously received other treatments
- •At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
- •Those who already have esophageal perforation or are at high risk of esophageal perforation
- •Patients whose tumors invade close to large blood vessels and are at risk of bleeding in the
- •there are active infections, such as active tuberculosis and hepatitis
- •There are contraindications to immunotherapy.
- •Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures
- •Combined with serious cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or a history of myocardial infarction within the past 6 months; and those combined with other uncontrolled acute and chronic diseases such as hypertension and diabetes.
- •Violation of inclusion and exclusion criteria, or other reasons that the researcher believes cannot continue the study of drug treatment.
研究组 & 干预措施
Inductive chemoimmunotherapy+chemoradiotherapy±surgery
In this group, the patients were given 2 cycles of inductive therapy of cardonilizumab combined with chemotherapy, followed by concurrent chemoradiotherapy with two cycles of nab-paclitaxel and cisplatin plus radiotherapy of 50-50.4 Gy. After clinical evaluation, surgery was feasible for a part of patients.
干预措施: Cardonilizumab (Drug)
Inductive chemoimmunotherapy+chemoradiotherapy±surgery
In this group, the patients were given 2 cycles of inductive therapy of cardonilizumab combined with chemotherapy, followed by concurrent chemoradiotherapy with two cycles of nab-paclitaxel and cisplatin plus radiotherapy of 50-50.4 Gy. After clinical evaluation, surgery was feasible for a part of patients.
干预措施: Chemoradiotherapy ±immunotherapy (Radiation)
Inductive chemoimmunotherapy+chemoradiotherapy±surgery
In this group, the patients were given 2 cycles of inductive therapy of cardonilizumab combined with chemotherapy, followed by concurrent chemoradiotherapy with two cycles of nab-paclitaxel and cisplatin plus radiotherapy of 50-50.4 Gy. After clinical evaluation, surgery was feasible for a part of patients.
干预措施: Radical surgery (Procedure)
结局指标
主要结局
Event-free survival
时间窗: 1-year
Time from treatment initiation to locoregional or distant recurrence, or death from any cause.
次要结局
- Adverse events(1-year)
- Distant metastasis free survival(1-year)
- Locoregional recurrence free survival(1-year)
- Overall survival(1-year)
研究者
Jianjun Qin
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences