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Organ-Specific Differences in Immunotherapy Response Among Metastatic Cancer Patients

3. juni 2026 opdateret af: Wenlong Zhong, MD

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

938

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Metastatic cancers treated with immune checkpoint inhibitors

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Organ-Specific Objective Response Rate (osORR)
Tidsramme: 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.
At first radiographic assessment after immunotherapy initiation (approximately 6-12 weeks).
Organ-Specific Progression-Free Survival (osPFS)
Tidsramme: 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.
Up to 5 years.
Overall Survival (OS)
Tidsramme: 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.
From start of ICB treatment until death from any cause (up to 5 years).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wenlong Zhong, MD

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2016

Primær færdiggørelse (Faktiske)

20. maj 2026

Studieafslutning (Faktiske)

20. maj 2026

Datoer for studieregistrering

Først indsendt

28. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SYSKY-2025-902-01

Plan for individuelle deltagerdata (IPD)

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