Sintilimab Combined With Chemotherapy Induction Therapy Followed by Concurrent Chemoradiotherapy vs. Concurrent Chemoradiotherapy for Esophageal Cancer: A Randomized Controlled Phase Ⅲ Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Overall survival rate
研究概览
简要总结
The objective of this clinical trial is to determine whether the addition of immunotherapy combined with chemotherapy before chemoradiotherapy can increase the survival rate of patients with esophageal cancer. It will also assess the safety of this regimen. The primary questions it aims to answer include:
- Can the addition of immunotherapy combined with chemotherapy before chemoradiotherapy reduce the rate of disease recurrence among participants?
- What adverse reactions will participants experience during the treatment process?
- Compared with traditional chemoradiotherapy, will this regimen extend the survival period of participants?
Participants will:
- Undergo two cycles of immunotherapy combined with chemotherapy, administered every three weeks, followed by concurrent chemoradiotherapy, which includes 28 sessions of radiotherapy and five sessions of chemotherapy during the concurrent period; or proceed directly to concurrent chemoradiotherapy, and then receive two cycles of chemotherapy after the completion of radiotherapy, administered once a month.
- Undergo regular tests and examinations to evaluate efficacy and safety.
- Record symptoms that occur during the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate and provide written informed consent;
- •Age 18-75 years, regardless of gender;
- •Histologically or cytologically confirmed esophageal squamous cell carcinoma;
- •Patients with inoperable esophageal cancer;
- •Clinical stage Ⅱ-ⅣA (AJCC 8th edition esophageal cancer staging system, including stage ⅣB with supraclavicular lymph node metastasis but excluding other distant metastatic stage ⅣB);
- •ECOG performance status 0-1;
- •Expected survival ≥ 3 months;
- •No severe dysfunction of hematopoietic, cardiac, pulmonary, hepatic, or renal systems, nor immune deficiency; Neutrophils ≥ 1.5×10⁹/L; hemoglobin ≥ 9 g/dL; platelets ≥ 100×10⁹/L; total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; creatinine ≤ 1.5 × ULN.
排除标准
- •Esophageal perforation or hematemesis;
- •Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (patients with hypothyroidism stable on hormone replacement therapy for ≥4 weeks with TSH/FT4 within normal range may be included); additionally, patients who have used immunosuppressants within 28 days will be excluded, except for steroid use for managing chemoradiation-related toxicities;
- •Previous or ongoing treatment with other types of PD-1 antibodies, or prior immunotherapy targeting PD-1/PD-L1;
- •Known allergic reaction to macromolecular protein drugs or sintilimab or any of its formulation components;
- •Uncontrolled cardiac disease or clinical symptoms, such as: a. heart failure of NYHA class II or above; b. unstable angina; c. myocardial infarction within the past year; d. supraventricular or ventricular arrhythmias requiring clinical intervention;
- •Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection), or active tuberculosis;
- •Active infection, or unexplained fever (body temperature >38.5℃) within 2 weeks prior to screening (fever judged by the investigator to be due to the tumor itself may be allowed);
- •Male or female participants of childbearing potential who refuse to use contraception during the study; or female patients who are pregnant or breastfeeding;
- •Other conditions judged by the investigator that may lead to premature termination of the study, such as co-existing severe diseases (including psychiatric disorders) requiring combined treatment, or family/social factors that may affect participant safety or integrity of the trial data.
研究组 & 干预措施
Standard group
Patients receive concurrent chemoradiotherapy (weekly paclitaxel/carboplatin with radiotherapy), followed by 2 cycles of consolidation chemotherapy (4-weekly paclitaxel/carboplatin).
干预措施: Definitive Radiotherapy (Radiation)
Induction group
Patients receive induction therapy with sintilimab plus 3-weekly paclitaxel/carboplatin for 2 cycles, followed by concurrent chemoradiotherapy (weekly paclitaxel/carboplatin plus radiotherapy).
干预措施: Sintilimab (Biological)
Induction group
Patients receive induction therapy with sintilimab plus 3-weekly paclitaxel/carboplatin for 2 cycles, followed by concurrent chemoradiotherapy (weekly paclitaxel/carboplatin plus radiotherapy).
干预措施: 3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy (Drug)
Induction group
Patients receive induction therapy with sintilimab plus 3-weekly paclitaxel/carboplatin for 2 cycles, followed by concurrent chemoradiotherapy (weekly paclitaxel/carboplatin plus radiotherapy).
干预措施: Weekly TC Chemotherapy (Drug)
Induction group
Patients receive induction therapy with sintilimab plus 3-weekly paclitaxel/carboplatin for 2 cycles, followed by concurrent chemoradiotherapy (weekly paclitaxel/carboplatin plus radiotherapy).
干预措施: Definitive Radiotherapy (Radiation)
Standard group
Patients receive concurrent chemoradiotherapy (weekly paclitaxel/carboplatin with radiotherapy), followed by 2 cycles of consolidation chemotherapy (4-weekly paclitaxel/carboplatin).
干预措施: Weekly TC Chemotherapy (Drug)
Standard group
Patients receive concurrent chemoradiotherapy (weekly paclitaxel/carboplatin with radiotherapy), followed by 2 cycles of consolidation chemotherapy (4-weekly paclitaxel/carboplatin).
干预措施: Four-Weekly TC Consolidation Chemotherapy (Drug)
结局指标
主要结局
Overall survival rate
时间窗: From the date of randomization to 3 years or until death, whichever comes first.
次要结局
- Progression-free survival(From the date of randomization to 3 years or until disease progression or death, whichever occurs first.)
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0(For the duration of treatment plus 30 days after the last dose.)
- Objective response rate(One month after the completion of treatment.)
研究者
Ye jinjun
Chief Physician, Department of Radiation Oncology
Jiangsu Cancer Institute & Hospital