Organ-Specific Differences in Immunotherapy Response Among Metastatic Cancer Patients

NCT07631611 | Completed DMC

• 1 other identifier: SYSKY-2025-902-01
• Study Type: observational
• Target: 938
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumors; Metastatic Cancer to Liver; Metastatic Cancer to the Bone; Brain Metastasis; Metastatic Cancers; Tumor Immune Microenvironment; Metastatic Cancer to the Lung; Immune Checkpoint Inhibitors

Outcome Measures

Primary Outcomes (3)

• Organ-Specific Objective Response Rate (osORR)

  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.

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

• Organ-Specific Progression-Free Survival (osPFS)

  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.

  Up to 5 years.

• Overall Survival (OS)

  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.

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

Study Arms (1)

Metastatic cancers treated with immune checkpoint inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes adults with solid tumors who developed metastatic cancer in the brain, liver, lung, or bone. All participants received first-line or second-line immune checkpoint inhibitor (ICB) therapy and completed at least three treatment cycles with available imaging follow-up. The study population represents real-world patients treated at Sun Yat-sen Memorial Hospital, the Third Affiliated Hospital of Sun Yat-sen University, and the First Affiliated Hospital of Chongqing Medical University, with complete clinical and survival data that allow evaluation of organ-specific treatment response and progression. Individuals with unclear metastatic sites, incomplete treatment information, or major data gaps were not included.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wenlong Zhong, MD: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Brain Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 8, 2026
• Study Start: January 1, 2016
• Primary Completion: May 20, 2026
• Study Completion: May 20, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)