Organ-Specific Differences in Immunotherapy Response Among Metastatic Cancer Patients

This study examines how tumors in different metastatic organs respond to immune checkpoint inhibitor (ICB) therapy in real-world clinical practice. ICB therapy helps the immune system recognize and attack cancer cells, but treatment responses may vary depending on where the cancer has spread. Common metastatic sites such as the liver, brain, lung, and bone each have unique immune environments that may influence treatment outcomes.

The investigators will review the medical records of approximately 1,000 adults with solid tumors who received ICB therapy at Sun Yat-sen Memorial Hospital, the Third Affiliated Hospital of Sun Yat-sen University, and the First Affiliated Hospital of Chongqing Medical University since 2016. The study will compare treatment response, time until disease progression, and overall survival among patients with different metastatic sites. Additional outcomes include disease control, immunotherapy-related side effects, and concordance between primary and metastatic tumor responses.

The study will also analyze available molecular and immune-profiling datasets to explore biological mechanisms that may explain organ-specific differences in ICB response. The goal is to improve understanding of how metastatic sites influence immunotherapy effectiveness and to support future treatment decision-making.

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Key information

Conditions

Solid Tumors Brain Diseases Brain Metastasis Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Immune Checkpoint Inhibitors Metastatic Cancer to Liver Metastatic Cancer to the Bone Metastatic Cancer to the Lung Metastatic Cancers Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Tumor Immune Microenvironment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥18 years.
Pathologically confirmed solid tumor with a documented primary tumor site.
At least one metastatic site in the brain, liver, lung, or bone confirmed by imaging or pathology (single or multiple lesions allowed).
Received first-line or second-line immune checkpoint inhibitor (ICB) therapy, including PD-1, PD-L1, or CTLA-4 inhibitors, either alone or in combination.
Completed at least 3 cycles of ICB therapy.
At least one evaluable imaging follow-up after initiation of immunotherapy.
Available clinical and follow-up data, including treatment initiation date, response assessment, progression status, and survival status.
Meets institutional ethics requirements for retrospective studies.

Exclusion criteria

Unclear or undocumented metastatic site, or lack of imaging/pathologic evidence supporting metastasis.
ICB treatment regimen cannot be clearly determined (e.g., unclear combination therapy components).
Missing more than 20% of key clinical variables or incomplete follow-up data (e.g., missing PFS or OS information).
Received fewer than 3 cycles of ICB therapy.
Major treatment interruption or poor treatment adherence.
Concurrent active malignancy that may interfere with outcome assessment.
Severe immune-related disease (e.g., systemic lupus erythematosus) or organ transplantation requiring long-term immunosuppression.
Participation in another interventional clinical trial that may affect treatment evaluation.
Data errors or logical inconsistencies that cannot be resolved after review.

Treatment and study plan

Primary outcomes

Organ-Specific Objective Response Rate (osORR)

Time frame: At first radiographic assessment after immunotherapy initiation (approximately 6-12 weeks).

osORR is the percentage of patients whose tumors in a specific metastatic organ (brain, liver, lung, or bone) achieve a complete response (CR) or partial response (PR) following immunotherapy, as assessed according to RECIST v1.1. Each metastatic organ is evaluated separately.
Organ-Specific Progression-Free Survival (osPFS)

Time frame: Up to 5 years.

osPFS is defined as the time from initiation of immunotherapy to disease progression within the specific metastatic organ or death from any cause, whichever occurs first. Progression is assessed according to RECIST v1.1 based on target lesions within the corresponding organ, regardless of progression occurring in other organs.
Overall Survival (OS)

Time frame: From start of ICB treatment until death from any cause (up to 5 years).

In this retrospective study, OS is defined as the time from initiation of immune checkpoint blockade (ICB) therapy to death from any cause. Survival time is determined using available longitudinal follow-up records. Patients who are alive at the last follow-up will be censored.

Sponsors and collaborators

Lead sponsor

Wenlong Zhong, MD

Other

Collaborators

First Affiliated Hospital of Chongqing Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University

Registry information

Official study title

Real-world Evidence and Multi-omics Insights Into Differential Immunotherapy Responses Between Primary and Metastatic Sites

Important dates

Study start: 2016
Primary completion: 2026
Study completion: 2026
First posted: Jun 8, 2026
Registry last updated: Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed