CompletedNot Applicable

Organ-Specific Differences in Immunotherapy Response Among Metastatic Cancer Patients

China938 participantsStarted 2016-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. *…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Organ-Specific Objective Response Rate (osORR)

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

Organ-Specific Progression-Free Survival (osPFS)

Timeframe: Up to 5 years.

Overall Survival (OS)

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

Trial details

NCT IDNCT07631611

SponsorWenlong Zhong, MD

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-20

View on ClinicalTrials.gov More Solid Tumors trials