NCT07266480招募中2 期
A Randomised, Controlled Clinical Study of Adebrelizumab for the Adjuvant Treatment of Esophageal Squamous Cell Cancer.
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2025年9月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
Evaluating the efficacy and safety of adebrelizumab for the adjuvant treatment of esophageal squamous cell cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age:≥18 years old, male or female; 2.Histopathologically confirmed esophageal squamous cell cancer with initial clinical stage cT1b-2N1-3M0 or cT3-4aN0-3M0 in the thoracic esophagus; 3.Radical surgery with R0 resection 4-16 weeks prior to randomisation; 4.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 5.Expected survival ≥ 12 months; 6.Left ventricular ejection fraction is >50%; 7.Normal functioning of major organs, i.e. meeting the following criteria:
- •routine blood tests:
- •ANC≥1.5×109/L；
- •PLT≥100×109/L；
- •biochemical examination:
- •ALT and AST<2.5ULN（liver metastasis: ALT and AST<5ULN）；
- •TBIL≤1.5ULN；
- •creatinine ≤1.5ULN； 8.Participants were willing to join in this study, written informed consent, good adherence and co-operation with follow up.
排除标准
- •Patients initially diagnosed as unresectable (e.g. large metastatic lymph nodes) and treated with conversion therapy;
- •Patients with severe postoperative complications who are not suitable for adjuvant therapy;
- •Patients who have received any form of adjuvant therapy after surgery;
- •Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy;
- •Pre-existing other malignancies, unless complete remission was achieved at least 5 years prior to enrolment and no other treatment is expected to be required during the study period;
- •Patients with active, known or suspected autoimmune disease, including but not limited to: interstitial pneumonitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma/allergies that have been in complete remission and do not require any intervention in adulthood may be considered for inclusion, but medical intervention with bronchodilator is required patients may not be included;
- •People with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
- •Pregnant or breastfeeding women and women of childbearing age with a history of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation who are not using contraception during the trial period;
- •Presence of clinically uncontrolled cardiac symptoms or disease, including but not limited to, such as (1) NYHA class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 6 months, (4) clinically significant supraventricular or ventricular arrhythmia not clinically intervened with or poorly controlled after clinical intervention;
- •Not suitable for enrolment in the investigator's comprehensive assessment.
研究组 & 干预措施
Adebrelizumab
Experimental
Adebrelizumab: 1200mg, iv, d1, q3w, 17 cycles
干预措施: Adebrelizumab (Drug)
结局指标
主要结局
DFS
时间窗: 3 years
DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.
次要结局
- OS(3 years)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](3 years)
- Patient reported outcome (Quality of Life questionnaire of cancer patients)(At the end of Cycle 1 (each cycle is 21 days))
研究者
研究点 (1)
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