Real-World Study on the Efficacy of Immunotherapy for Pan-Cancer Lymph Node Metastatic Tumors and Its Influencing Factors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) at the primary tumor (T) level
研究概览
简要总结
Lymph node metastasis is a key stage of malignant tumor progression and a core factor affecting the efficacy of immunotherapy. The therapeutic response of lymph node metastases to immune checkpoint inhibitors (ICIs) varies significantly among different cancer types, and the underlying regulatory mechanisms remain unclear. This single-center, retrospective observational study was approved by the Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University (Approval No.: SYSKY-2026-278-01). We plan to enroll no less than 5000 patients with pan-cancer lymph node metastasis who received ICI therapy in our hospital. The efficacy of primary tumors (T) and metastatic lymph nodes (N) before and after immunotherapy will be evaluated based on TNM staging changes, and the objective response rate (ORR) at both levels will be calculated. Patients will be divided into two groups according to the use of β-blockers during immunotherapy to compare the ORR differences, and explore the clinical factors affecting the efficacy of immunotherapy for pan-cancer lymph node metastases. This study aims to provide evidence-based medical basis for formulating individualized immunotherapy strategies for pan-cancer lymph node metastasis.
详细描述
This is a single-center, retrospective observational study conducted at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, approved by the hospital's Ethics Committee (Approval No.: SYSKY-2026-278-01). The study aims to systematically evaluate the efficacy of immune checkpoint inhibitor (ICI) immunotherapy in patients with pan-cancer lymph node metastases, and to explore the influencing factors of efficacy, especially the regulatory effect of β-blocker use on the response of metastatic lymph nodes to immunotherapy.
- Study Background Lymph node metastasis is a critical stage in the progression of various malignant solid tumors, and is an independent risk factor for poor prognosis in patients. In recent years, immune checkpoint inhibitors (ICIs) represented by PD-1/PD-L1 inhibitors have significantly improved the survival of patients with multiple advanced cancers, becoming a core treatment modality for malignant tumors. However, the response of metastatic lymph nodes to immunotherapy is often inconsistent with that of primary tumors, and the efficacy varies greatly among different cancer types. At present, most relevant studies focus on the efficacy of primary tumors, and there is a lack of systematic pan-cancer analysis focusing on the response of metastatic lymph nodes to immunotherapy. In addition, preclinical and clinical studies have shown that β-blockers can regulate the tumor immune microenvironment, enhance the anti-tumor effect of immunotherapy, and improve the prognosis of patients. However, whether β-blockers can improve the response of metastatic lymph nodes to immunotherapy in pan-cancer populations has not been systematically verified. This study fills this gap by conducting a real-world retrospective analysis of a large sample of pan-cancer patients with lymph node metastasis who received immunotherapy.
- Study Objectives Primary Objectives To evaluate the objective response rate (ORR) of metastatic lymph nodes (N stage) and primary tumors (T stage) in patients with pan-cancer lymph node metastasis after ICI immunotherapy.
To compare the difference in ORR of metastatic lymph nodes between patients who received β-blockers during immunotherapy and those who did not.
Secondary Objectives To analyze the consistency of therapeutic response between primary tumors and metastatic lymph nodes in the same patient.
To calculate the downstaging rate of T stage, N stage and overall TNM stage after immunotherapy, and the disease control rate (DCR) at T and N levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •- Histopathologically or cytologically confirmed malignant solid tumors (including non-small cell lung cancer, small cell lung cancer, gastric cancer, colorectal cancer, bladder cancer, breast cancer, esophageal cancer, liver cancer, pancreatic cancer, melanoma, etc.) Confirmed regional or distant lymph node metastasis by imaging (enhanced CT/MRI/PET-CT) or pathological examination Received at least 1 cycle of ICI therapy (monotherapy or combined therapy) with clear treatment initiation time and regimen records Complete clinical diagnosis, treatment, efficacy evaluation and follow-up records, with available baseline and post-immunotherapy imaging for T/N stage assessment Evaluable tumor lesions according to the RECIST 1.1 criteria Clear β-blocker use records in medical records Aged ≥18 years, regardless of gende
排除标准
- •Less than 1 cycle of ICI therapy, unevaluable efficacy, or missing medication time/regimen information Incomplete clinical records with missing key data for analysis Complicated with other synchronous or metachronous malignant tumors Received other anti-tumor immunotherapy before ICI therapy (e.g., adoptive cell therapy, tumor vaccine) Unclear diagnosis of lymph node metastasis or unlocatable/evaluable lymph node metastatic lesions Pregnant women, or patients whose data cannot be desensitized or meet ethical/data compliance requirements Imaging cannot distinguish the changes of primary tumors and lymph node lesions
研究组 & 干预措施
β-blocker combined with immunotherapy group
Patients who received β-blocker administration during immune checkpoint inhibitor (ICI) immunotherapy
Immunotherapy alone group (control group)
Patients who received ICI immunotherapy without β-blocker administration
结局指标
主要结局
Objective Response Rate (ORR) at the primary tumor (T) level
时间窗: 6-12 weeks after the initiation of immunotherapy
Proportion of patients with decreased T stage after immunotherapy (downstaging = response; stable/elevated T stage = non-response/progression)
Objective Response Rate (ORR) at the metastatic lymph node (N) level
时间窗: 6-12 weeks after the initiation of immunotherapy
Proportion of patients with decreased N stage after immunotherapy (downstaging = response; stable/elevated N stage = non-response/progression)
Effect of β-blocker administration on N-level ORR
时间窗: 6-12 weeks after the initiation of immunotherapy
Comparison of metastatic lymph node ORR between the β-blocker combined group and the immunotherapy alone control group
次要结局
- Consistency of T and N efficacy(6-12 weeks after the initiation of immunotherapy)
- Outcome Measure:(6-12 weeks after the initiation of immunotherapy)