A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (PCR)
研究概览
简要总结
Esophageal cancer is a prevalent digestive tract tumor, with around 400,000 new cases and 300,000 deaths globally each year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma (ESCC) patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate.
Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of ESCC. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect.
The results of the Phase 1b trial evaluating adbelimumab monotherapy as a neoadjuvant treatment for locally advanced resectable ESCC demonstrated that patients receiving two cycles of neoadjuvant sequential surgery exhibited favorable safety profiles, with no adverse reactions of grade 3 or higher. The trial reported a major pathological response (MPR) rate of 24%, a pathological complete response (pCR) rate of 8%, a 2-year overall survival (OS) rate of 92%, and a 2-year recurrence-free survival (RFS) rate of 100%. The effectiveness of combining adbelizumab with chemotherapy and targeted therapy for locally advanced esophageal cancer is uncertain.
This study aims to assess the efficacy and safety of using adbelizumab with chemotherapy and apatinib as neoadjuvant therapy for resectable 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Patients age 18 to 75 years old.
- •Primary resectable, histologically confirmed esophageal squamous cell cancer.
- •Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition).
- •No distant metastasis, the diseases could be resectable assessed by thoracic oncologist.
排除标准
- •With significant cardiovascular disease.
- •Current treatment with anti-viral therapy or HBV.
- •Female patients who are pregnant or lactating.
- •History of malignancy within 5 years prior to screening.
- •Active or history of autoimmune disease or immune deficiency.
- •Signs of distant metastases.
研究组 & 干预措施
Adbelimumab, chemotherapy and apatinib
Preoperative neoadjuvant therapy for 4 cycles. Radical surgery is performed 4-6 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient. Adbelimumab can be aintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death.
干预措施: Adbelimumab, Albumin paclitaxel, Carboplatin, Apatinib (Drug)
Adbelimumab, chemotherapy and apatinib
Preoperative neoadjuvant therapy for 4 cycles. Radical surgery is performed 4-6 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient. Adbelimumab can be aintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death.
干预措施: Esophagectomy (Procedure)
Adbelimumab, chemotherapy and apatinib
Preoperative neoadjuvant therapy for 4 cycles. Radical surgery is performed 4-6 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient. Adbelimumab can be aintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death.
干预措施: Collecting samples from participant (Other)
结局指标
主要结局
Pathological Complete Response (PCR)
时间窗: 1 month after surgery
The pCR will be defined as the proportion of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment.
次要结局
- Major Pathological Response (MPR)(1 month after surgery)
- Objective Response Rate (ORR)(before surgery)
- The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients(3 months after surgery)
- 2-year and 5-year overall survival(2-year and 5-year after enrolled)
- Incidence of Treatment-related Adverse Events(1 month after surgery)
- R0 resection rate(1 month after surgery)