Real-World Study on Efficacy and Influencing Factors of Immunotherapy for Pan-Cancer Lymph Node Metastases.

NCT07540377 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Phase

Observational

Started

2026-03-30

Last updated

2026-04-20

Condition(s) studied

Malignant Solid Tumors With Lymph Node Metastasis

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: \- 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Objective Response Rate (ORR) at the primary tumor (T) level — 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 — 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 — 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

Trial sites (1)

Facility	City	Region	Status
Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07540377 on ClinicalTrials.gov ↗ ← All trials in China