NCT06861894尚未招募2 期
Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable Esophageal Squamous Cell Carcinoma
Zhigang Li1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2025年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- 2-year OS rate
研究概览
简要总结
In this prospective trial, patients demonstrating clinical complete response (cCR) as determined by a standard response assessment protocol (incorporating clinical and molecular diagnostic methods) will be offered organ-sparing management following neoadjuvant therapy with adebrelimab (anti-PD-L1) concurrent with chemoradiotherapy. The primary endpoint is 2-year overall survival rate in this watch-and-wait cohort.
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
- •Subjects signed the informed consent and volunteered to participate in the study.
- •Esophageal squamous cell carcinoma confirmed by histology or cytology.
- •Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as cII-III (AJCC 8th).
- •Expect to have R0 resection
- •In age from 18 to
- •ECOG PS: 0~
- •Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.
- •No contraindications to surgery.
- •Has sufficient organ function including (1) Blood routine: NE≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL/min（Cocheroft-Gault) (3) Coagulation function: INR≤1.5; APTT≤1.5×ULN
- •Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male subjects with childbearing age female partners, must take contraceptive measures from the first dose to three months after last administration.
- •Good compliance, willing to comply with follow-up schedules.
排除标准
- •Subjects have received or are receiving any of:
- •anti-tumor interventions such as radiotherapy, chemotherapy, or other medications.
- •immunosuppressants or systemic glucosteroids (prednisone equivalence> 10mg/d) within 2 weeks before the first administration, inhaled or topical use of glucosteroids (prednisone equivalence>10mg/d) is allowed if no known active autoimmune disease.
- •live vaccine within 4 weeks before the first administration.
- •major surgery or major injury within 4 weeks before the first administration.
- •Cancer-related exclusion criteria
- •other cancers instead of ESCC
- •unresectable or metastatic ESCC
- •not comply with cⅡ-Ⅲ（cT2N1-2M0 or cT3N0-2M0, AJCC 8th）
- •Subjects with other malignant tumors within 5 years before the first administration, but subjects with cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, localized prostate cancer received radical surgery and ductal carcinoma in situ that have received radical treatment and do not need other treatment can be included)
- •Other criteria
- •Subjects have uncontrolled cardiovascular diseases, such as 1) heart failure ≥ NYHA class 2, 2) unstable angina 3) myocardial infarction within 1 year; 4) supraventricular or ventricular arrhythmia that needs treatment
- •Subjects with any known active autoimmune disease
- •Pregnant or breastfeeding female
- •Presence of allergy or hypersensitivity to investigational medications
- •HIV-positive or active hepatitis B (HBsAg positive and HBV-DNA ≥2000 IU/ml or ≥ 104 copies/mL) or active hepatitis C (HCV antibody positive) or active tuberculosis
- •Investigators assessed there might be other factors that cause subjects to withdraw.
研究组 & 干预措施
perioperative treatment with adebrelimab and CRT
Experimental
干预措施: Adebrelimab and nab-paclitaxel and carboplatin (Drug)
perioperative treatment with adebrelimab and CRT
Experimental
干预措施: Radiation (Radiation)
perioperative treatment with adebrelimab and CRT
Experimental
干预措施: standard oesophagectomy (Procedure)
perioperative treatment with adebrelimab and CRT
Experimental
干预措施: active surveillance (Other)
结局指标
主要结局
2-year OS rate
时间窗: 24 months
An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.
次要结局
- cCR rate(12 months)
- median EFS(24 months)
- median OS(24 months)
- Incidence, type and severity of adverse events as assessed by CTCAE 5.0(24 months)
- quality of life (QOL)(24 months)
- quality of life (QOL) assessed by EORTC QLQ-OES18(24 months)
研究者
Zhigang Li
Chief of Department of Esophageal Surgery
Shanghai Chest Hospital
研究点 (1)
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