NCT06178211尚未招募2 期
Neoadjuvant Adebrelimab Plus Chemotherapy for Resectable ESCC: a Single Arm, Prospective Phase 2 Clinical Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- pCR rate
研究概览
简要总结
The investigators will conduct a single-arm prospective study to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab (SHR-1316) and chemotherapy in patients with resectable esophageal squamous cell carcinoma (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
- •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 medictions.
- •immunosuppresants 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
- •non-recetable 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 arrthymia 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 withdrawl.
结局指标
主要结局
pCR rate
时间窗: 12 months
The primary endpoint is a pCR rate, which is defined as the absence of any remaining tumor cells in both the main tumor and the nearby lymph nodes (ypT0N0) as per the AJCC 8th Edition TRG scoring system.
次要结局
- cCR rate(12 months)
- R0 resection rate(12 months)
- MPR rate(12 months)
- median EFS(12 months)
- median OS(12 months)
- Incidence, type and severity of adverse events as assessed by CTCAE 5.0(From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose)
- Potential biomarkers such as ctDNA or PD-L1 expression(12 months)
研究者
Zhigang Li
Chief of Department of Esophageal Surgery
Shanghai Chest Hospital
研究点 (1)
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