A Pan-Cancer Retrospective Study on the Relationship Between Tumor Microenvironment Composition and Efficacy of Antibody-Based Antitumor Therapy
7 maggio 2026 aggiornato da: Tianjin Medical University Cancer Institute and Hospital
This study is a single-center, retrospective, observational cohort investigation conducted at Tianjin Cancer Hospital that aims to evaluate the relationship between tumor microenvironment (TME) composition and the efficacy of antibody-based antitumor therapies-including monoclonal antibodies, antibody-drug conjugates, and bispecific antibodies-across a pan-cancer population comprising adult patients with breast, colorectal, head and neck squamous, lung, bladder, gastric, or pancreatic cancer treated between January 2020 and January 2026.
Using real-world data extracted from electronic medical records, pathology archives, and laboratory systems, the study will analyze TME-related variables derived from tissue immunohistochemistry, molecular testing, and peripheral blood inflammatory markers in relation to clinical outcomes, with a primary endpoint of either progression-free survival or objective response rate to be finalized before database lock, and secondary endpoints including overall survival, disease control rate, and subgroup heterogeneity across cancer types and drug classes.
Statistical analyses will employ Kaplan-Meier survival curves, Cox proportional hazards models, logistic regression, and appropriate multivariable adjustments with sensitivity analyses using propensity score methods, while the study will adhere to ethical standards under a waiver of informed consent due to its minimal-risk, retrospective design and strict de-identification of patient data.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Tipo di studio
Osservativo
Iscrizione (Stimato)
300
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Cina
- Tianjin Medical University Cancer Institute & Hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione di probabilità
Popolazione di studio
This retrospective cohort study includes adult patients (≥18 years) with pathologically confirmed breast, colorectal, head and neck squamous, lung, bladder, gastric, or pancreatic cancer who received at least one line of antibody-based antitumor therapy-including monoclonal antibodies, antibody-drug conjugates (ADCs), and bispecific antibodies-at Tianjin Cancer Hospital between January 2020 and January 2026.
Eligible patients must have completed at least one cycle of efficacy evaluation with available radiologic or clinical response records, possess complete key clinical data (demographics, staging, treatment details, and follow-up outcomes), and have at least one tumor microenvironment (TME)-related assessment available from tissue immunohistochemistry, molecular testing, or peripheral blood inflammatory markers.
Patients are excluded if they lack critical efficacy or exposure data, have a concurrent active malignancy with indistinguishable outcome attribution, present with severely i
Descrizione
Inclusion Criteria:
- Age 18 years or older
- Pathologically confirmed diagnosis of breast cancer, colorectal cancer, head and neck squamous cell carcinoma, lung cancer, bladder cancer, gastric cancer, or pancreatic cancer
- Received antibody-based antitumor therapy at this center, including monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, or other antibody-based agents, either as monotherapy or combination therapy
- Completed at least one post-treatment efficacy assessment or had evaluable radiographic or clinical documentation of treatment response
- Available key clinical information, including demographics, tumor stage, line of therapy, treatment details, efficacy outcomes, or follow-up data
- Available data for at least one tumor microenvironment-related indicator, including tissue immunohistochemistry, molecular testing, or peripheral blood inflammatory markers
Exclusion Criteria:
- Missing key outcome information, including unevaluable treatment response or absence of follow-up or survival outcome records
- Missing key exposure information, including antibody-based therapy drug name or timing/line of therapy
- Concurrent active malignancy for which treatment outcomes cannot be clearly attributed to the cancer of interest
- Severely incomplete or unverifiable medical records
- Received only supportive or palliative care without exposure to antibody-based antitumor therapy
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Adult patients with any of seven solid tumors who received antibody-based therapy (2020-2026)
The study cohort comprises adult patients (≥18 years) with pathologically confirmed diagnoses of breast, colorectal, head and neck squamous, lung, bladder, gastric, or pancreatic cancer who received at least one line of antibody-based antitumor therapy-including monoclonal antibodies, antibody-drug conjugates (ADCs), or bispecific antibodies-at Tianjin Cancer Hospital between January 1, 2020, and January 1, 2026.
Eligible cases must have at least one evaluable efficacy assessment and available tumor microenvironment-related data derived from tissue immunohistochemistry, molecular profiling, or peripheral blood inflammatory indices.
The cohort is derived retrospectively from real-world electronic medical records, pathology archives, and laboratory information systems, with an anticipated sample size of approximately 200-500 analyzable cases to support multivariable modeling and subgroup explorations across cancer types and drug classes.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Spearman correlation coefficient between tumor microenvironment marker levels and objective response rate/progression-free survival
Lasso di tempo: January 2020 and January 2026
|
Tumor microenvironment markers, including NETosis-related markers and immune-cell composition, will be quantified by multiplex immunofluorescence as percentage of marker-positive area or percentage of marker-positive cells.
Treatment efficacy will be assessed by objective response rate according to RECIST 1.1, and prognosis will be assessed by progression-free survival and overall survival.
Spearman correlation coefficients will be calculated to evaluate the correlation between tumor microenvironment marker levels and treatment outcomes.
|
January 2020 and January 2026
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
To evaluate the predictive value of TME indicators for efficacy outcomes (e.g., AUC, calibration, decision curve analysis, etc., to be conducted as data permit).
Lasso di tempo: January 2020 and January 2026
|
January 2020 and January 2026
|
|
|
Subgroup-specific Spearman correlation coefficient between tumor microenvironment marker levels and objective response rate
Lasso di tempo: January 2020 and January 2026
|
Tumor microenvironment markers will be measured in pretreatment tumor tissue by multiplex immunofluorescence and reported as the percentage of marker-positive cells or marker-positive area.
Objective response rate will be defined as the percentage of patients with complete or partial response according to RECIST 1.1.
Spearman correlation coefficients will be calculated within predefined subgroups, including cancer type, antibody target/type, and line of therapy.
|
January 2020 and January 2026
|
|
Interaction term odds ratio for clinical factors modifying the association between tumor microenvironment marker levels and objective response
Lasso di tempo: January 2020 and January 2026
|
Tumor microenvironment markers will be measured in pretreatment tumor tissue using multiplex immunofluorescence and reported as the percentage of marker-positive cells or marker-positive area.
Objective response will be defined as complete or partial response according to RECIST 1.1.
Multivariable logistic regression will be used to assess interaction terms between tumor microenvironment marker levels and predefined clinical factors, with results reported as odds ratios and 95% confidence intervals.
|
January 2020 and January 2026
|
|
To construct a multivariable predictive model or risk stratification tool where feasible
Lasso di tempo: January 2020 and January 2026
|
January 2020 and January 2026
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 marzo 2026
Completamento primario (Stimato)
30 giugno 2026
Completamento dello studio (Stimato)
30 giugno 2026
Date di iscrizione allo studio
Primo inviato
19 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
7 maggio 2026
Primo Inserito (Effettivo)
13 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 maggio 2026
Ultimo verificato
1 marzo 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- PRISM-AB
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .