A Single-Arm, Multicenter, Exploratory Clinical Study of Adebrelimab in Combination With Gemcitabine, Cisplatin, and Simvastatin for the Treatment of Patients With Locally Advanced or Metastatic Biliary Tract Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study will investigate the safety and effectiveness of a new combination treatment for patients with advanced bile duct cancer. The treatment combines standard chemotherapy drugs (gemcitabine and cisplatin) with two additional medications: adebrelimab and simvastatin.
All participants in this study will receive the same four-drug combination. Researchers will closely monitor patients to see how well the tumors shrink, how long the treatment keeps the cancer from growing, and what side effects occur. The study is exploratory, meaning it aims to gather initial data on whether this four-drug combination is a promising approach for treating advanced biliary tract cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer).
- •No prior systemic therapy for advanced disease if initially diagnosed as unresectable or metastatic. Disease recurrence occurring more than 6 months after radical surgery or adjuvant therapy is allowed.
- •ECOG Performance Status of 0 or
- •At least one radiologically measurable lesion as defined by RECIST 1.1 criteria (tumor lesion with longest diameter ≥10 mm on CT scan, or lymph node with short axis ≥15 mm).
- •No severe dysfunction of major organs (heart, lungs, brain, etc.).
排除标准
- •Diagnosis of ampullary carcinoma.
- •Presence of active or previously documented autoimmune or inflammatory disorders.
- •Known hypersensitivity to any component of the study drugs (adebrelimab, gemcitabine, cisplatin, simvastatin).
- •Severe liver dysfunction: laboratory tests within 14 days prior to enrollment showing total bilirubin > 1.5 times the upper limit of normal (ULN), AND/OR alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times ULN.
- •Participation in another investigational drug or device clinical trial within 4 weeks prior to enrollment.
- •Inability to comply with the study protocol for treatment or scheduled follow-up assessments.
- •Any other condition deemed by the investigator as unsuitable for participation in the study.
研究组 & 干预措施
Single Group Intervention
All participants receive the combination therapy of adebrelimab, gemcitabine, cisplatin, and simvastatin for up to 8 cycles (21-day/cycle), followed by maintenance therapy with adebrelimab and simvastatin until disease progression or unacceptable toxicity.
干预措施: Gemcitabine + Cisplatin (Drug)
Single Group Intervention
All participants receive the combination therapy of adebrelimab, gemcitabine, cisplatin, and simvastatin for up to 8 cycles (21-day/cycle), followed by maintenance therapy with adebrelimab and simvastatin until disease progression or unacceptable toxicity.
干预措施: Adebrelimab (Drug)
Single Group Intervention
All participants receive the combination therapy of adebrelimab, gemcitabine, cisplatin, and simvastatin for up to 8 cycles (21-day/cycle), followed by maintenance therapy with adebrelimab and simvastatin until disease progression or unacceptable toxicity.
干预措施: Simvastatin 20mg (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From enrollment until the first documented disease progression or completion of study treatment, whichever occurs first, assessed up to approximately 2 years.
The proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Tumor assessments will be performed by investigators via contrast-enhanced CT or MRI scans.
次要结局
- Progression-Free Survival (PFS)(From enrollment until the first documented progression or death from any cause, assessed up to approximately 2 years)
- Overall Survival (OS)(From enrollment until death from any cause, assessed up to approximately 3 years.)
- Disease Control Rate (DCR)(From enrollment until the first documented disease progression or completion of study treatment, assessed up to approximately 2 years.)
- Duration of Response (DOR)(From the first documented response until disease progression or death, assessed up to approximately 2 years.)
- Incidence of Treatment-Related Adverse Events (TRAEs)(From the first dose of study treatment until 30 days after the last dose, assessed up to approximately 2 years.)