NCT07769866尚未招募不适用
Retlirafusp Alfa Combined With Definitive Concurrent Chemoradiotherapy in Local Advanced Unresectable Esophageal Squamous Cell Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- 1 year progression-free survival (PFS) rate
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of retlirafusp alfa combined with radical chemoradiotherapy in the treatment of locally advanced unresectable esophageal squamous cell carcinoma. Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy before standard concurrent chemoradiotherapy and retlirafusp alfa for maintenance treatment till one year.
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
- •Voluntarily sign the written informed consent form and agree to participate in this study;
- •Pathologically confirmed esophageal squamous cell carcinoma;
- •Staged as T2-4bN0-3M0 or TXNXM1 (with supraclavicular lymph node metastasis), diagnosed as unresectable locally advanced esophageal cancer (according to the American Joint Committee on Cancer (AJCC) 8th edition);
- •Aged 18-75 years, male or female;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.;
- •Adequate major organ function, meeting the following laboratory criteria:
- •Complete blood count: Neutrophil count ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Blood biochemistry: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min; Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
- •Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study drug, and must use effective contraception during the study period and for at least 3 months after the last dose; Male patients with female partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study period and for 3 months after the last dose.
排除标准
- •Prior or concurrent treatment with any of the following:
- •Any prior or ongoing radiotherapy, chemotherapy, or other anti-tumor agents for malignancy;
- •Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (at a dose > 10 mg/day of prednisone or equivalent) within 2 weeks prior to the first dose of study drug. Inhaled or topical corticosteroids, and adrenal hormone replacement at doses > 10 mg/day prednisone or equivalent, are permitted in the absence of active autoimmune disease;
- •Receipt of live attenuated vaccines within 4 weeks prior to the first dose of study drug;
- •Major surgery or severe trauma within 4 weeks prior to the first dose of study drug;
- •Tumor-related exclusion criteria:
- •Non-esophageal cancer patients;
- •Patients without unresectable locally advanced or metastatic esophageal cancer;
- •Diagnosis of another malignancy within 5 years prior to the first dose of study drug, with the exception of cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery;
- •Other criteria:
- •Poorly controlled cardiac symptoms or diseases, including: a) New York Heart Association (NYHA) class ≥ 2 heart failure; b) Unstable angina; c) Myocardial infarction within 1 year; d) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
- •Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthma requiring bronchodilators for medical intervention is excluded;
- •Pregnant or breastfeeding women;
- •History of severe allergic reactions to monoclonal antibodies, platinum agents, paclitaxel, or human serum albumin;
- •Human immunodeficiency virus (HIV)-positive patients, or patients with active hepatitis (hepatitis B reference: hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) ≥ 2000 IU/mL or ≥ 10⁴ copies/mL; hepatitis C reference: hepatitis C virus (HCV) antibody positive), or active pulmonary tuberculosis;
- •Any other condition that, in the investigator's judgment, may necessitate premature termination from the study.
结局指标
主要结局
1 year progression-free survival (PFS) rate
时间窗: From the date of first study treatment administration until the date of first documented progression or death from any cause, whichever comes first, assessed up to 1 year (12 months).
Progression-free survival (PFS) is defined as the time from the date of first study treatment administration to the first documented disease progression (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)) or death from any cause, whichever occurs first. The 1-year PFS rate is the proportion of participants who are alive and progression-free at 1 year (12 months) after the first dose.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Retlirafusp Alfa Injection Combined Chemotherapy for Perioperative Treatment of Esophagogastric Junction Adenocarcinoma: A Single-Arm, Phase II Study of Safety and EfficacyGEJ AdenocarcinomaNCT07493382Tianjin Medical University Cancer Institute and Hospital30
尚未招募
2 期
Conversion Therapy With Retlirafusp Alfa Plus Chemotherapy in Gastric or Gastroesophageal Junction AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaNCT07709767Tang-Du Hospital21
尚未招募
3 期
Retlirafusp Alfa Injection Plus Chemotherapy Versus Investigator's Choice of Anti-PD-1 Antibody Plus Chemotherapy as First-line Treatment for Advanced Gastric Cancer With Liver MetastasesGastric Adenocarcinoma and Gastroesophageal Junction AdenocarcinomaNCT07677293Peking University332
尚未招募
2 期
Relatrilfa-α Plus Single-Agent Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III NSCLC (Phase 2)NSCLCNCT07550920Tianjin Medical University Cancer Institute and Hospital18
尚未招募
2 期
Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Gastric or Gastroesophageal Junction CancerNCT07610629Henan Cancer Hospital50