NCT07135544招募中2 期
A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer
Yongjun Chen1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2025年8月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is an exploratory and prospective study, with the research subjects being patients with initially untreated and unresectable biliary tract tumors. The efficacy and safety of the treatment regimen consisting of Adebrelimab monoclonal antibody combined with targeted therapy and systemic chemotherapy were investigated.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological or histological diagnosis of malignant tumor of the biliary tract;
- •Patients who are classified as TxNx and TxNxM1 according to the UICC/AJCC TNM staging system (9th edition, 2024), and who, based on the judgment of the research team, meet the criteria for newly diagnosed incurable cases or are not suitable for surgery;
- •Age: 18-80 years old;
- •Expected survival period > 3 months;
- •Both genders are eligible;
- •ECOG PS score of 0 or 1;
- •No severe complications, such as hypertension, coronary heart disease, and history of mental illness, no severe allergy history; non-pregnant and non-lactating;
- •The patient's organ and hematological system functions meet the following requirements:
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- •Platelet count ≥ 75 × 10^9/L;
- •Hemoglobin ≥ 90 g/L;
- •Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN);
- •Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN;
- •Albumin ≥ 3 g/dL
- •Creatinine ≤ 1.5 x ULN
- •Patients can understand and sign the informed consent form to participate in the trial study; good compliance.
- •Newly diagnosed patients, who have not undergone any local or systemic treatment for the tumor in the past and have undergone radical resection surgery for biliary cancer, and whose disease recurs 2 years after the surgery can be included;
- •Patients with potential fertility should use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment and within 1 month after the end of the study treatment; and the serum or urine HCG test must be negative within 72 hours before the study enrollment, and must be non-lactating.
排除标准
- •Patients who received immune checkpoint inhibitors before enrollment, or those who directly received another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, CD137);
- •Patients who used any other investigational drug within 4 weeks before enrollment;
- •Patients with any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); children with asthma who have completely recovered after adulthood and do not require any intervention can be included, but patients requiring bronchodilator drug intervention cannot be included;
- •Congenital or acquired immune deficiencies, such as infection with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA > 500 IU/ml), hepatitis C (positive hepatitis C antibody, HCV-RNA above the detection limit of the analytical method), or co-infection of hepatitis B and hepatitis C;
- •Serious infections occurred within 4 weeks before the first administration (such as intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > 38.5°C during screening or before the first administration;
- •History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Having an uncontrolled mental disorder;
- •Concurrently having severe and/or uncontrollable diseases that may affect the participation in the study, such as unstable angina pectoris, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, poorly controlled diabetes, excessive activity, uncontrollable infection after insufficient biliary drainage (such as tumor blocking the bile duct);
- •Other cancers that occurred in the past (within the past 5 years) or simultaneously, excluding non-melanoma skin cancer and carcinoma in situ;
- •History of allergy or hypersensitivity to any study drug or any monoclonal antibody;
- •Unable or unwilling to sign the informed consent form.
研究组 & 干预措施
Adebrelimab combined with the GC regimen and Apatinib
Experimental
Adebrelimab 1200mg, intravenous infusion, on day 1, repeated every 3 weeks; Gemcitabine 1000mg/m2, on days 1 and 8, every 3 weeks Cisplatin 50mg/m2, on day 1, every 3 weeks Apatinib 250mg, once daily, orally
干预措施: Adebrelimab combined with the GC regimen and Apatinib (Drug)
结局指标
主要结局
ORR
时间窗: At the end of Cycle 6 and 10 (each cycle is 21 days)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
次要结局
- DCR(up to 18 months)
- PFS(up to 24 months)
- OS(up to 24 months)
- AE(up to 24 months)
研究者
Yongjun Chen
Director
Tongji Hospital
研究点 (1)
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