A Single-Arm, Multicenter, Exploratory Study of Lenvatinib Combined With PD-1 Inhibitor in Advanced Solid Tumors With Chromosome 11q13 Amplification
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The goal of this clinical trial is to learn if the combination of lenvatinib and a PD-1 inhibitor (a type of immunotherapy) works to treat advanced solid tumors that have a specific genetic change called "11q13 amplification". It will also learn about the safety of this combination. The main questions it aims to answer are:
How many participants' tumors shrink or stop growing after receiving the combination therapy? What side effects do participants have when taking this combination therapy? All participants in this study will receive the same drug combination. Researchers will look at the results to see how well the treatment works.
Participants will:
Take lenvatinib orally once daily and receive PD-1 inhibitor by intravenous infusion every 3 weeks.
Visit the clinic regularly for checkups, blood tests, and CT or MRI scans to see how the tumor is responding.
Be followed for side effects and survival over time.
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
- •Voluntary signing of the informed consent form, age ≥ 18 years at the time of signing, any gender.
- •Histologically or cytologically confirmed unresectable locally advanced or metastatic solid malignant tumor, including but not limited to: esophageal carcinoma, head and neck squamous cell carcinoma, breast cancer, lung cancer, hepatobiliary malignancies, and other solid tumors deemed eligible by the investigator.
- •Confirmed tumor presence of chromosome 11q13 amplification (amplification of at least one gene among CCND1, FGF3, FGF4, FGF19) via NGS testing.
- •No prior treatment with lenvatinib.
- •ECOG Performance Status of 0 or 1, with an estimated life expectancy ≥ 3 months.
- •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).
- •Adequate organ function.
排除标准
- •Presence of active or previously documented autoimmune or inflammatory disorders.
- •Known hypersensitivity to any component of the study drugs (lenvatinib or PD-1 inhibitors).
- •Significant bleeding tendency or coagulation dysfunction, or occurrence of major bleeding within 4 weeks prior to enrollment.
- •Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) despite medication.
- •Received chemotherapy, radiotherapy, major surgery, or other anticancer therapy within 4 weeks prior to enrollment.
- •Pregnant or lactating women, or patients of childbearing potential unwilling to use effective contraception.
- •Inability to comply with the study protocol for treatment or scheduled follow-up assessments.
研究组 & 干预措施
Lenvatinib + PD-1 Inhibitor Combination Therapy
This is a basket trial arm. All enrolled participants, regardless of their specific solid tumor type (e.g., esophageal carcinoma, head and neck squamous cell carcinoma, etc.), receive the same intervention: the combination of lenvatinib and a PD-1 inhibitor. Patients are eligible if they have advanced solid tumors with chromosome 11q13 amplification.
干预措施: Lenvatinib plus PD-1 Inhibitor (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From first dose of study treatment until the first documented disease progression or start of new anticancer therapy, whichever occurs first, assessed up to approximately 24 months.
Proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Tumor response will be assessed by investigators via contrast-enhanced CT or MRI scans.
次要结局
- Disease Control Rate (DCR)(From first dose until disease progression or start of new therapy, assessed up to 24 months.)
- Progression-Free Survival (PFS)(From first dose until progression or death, assessed up to 24 months.)
- Overall Survival (OS)(From first dose until death from any cause, assessed up to approximately 36 months.)
- Incidence of Treatment-Related Adverse Events (TRAEs)(From first dose until 30 days after the last dose.)