A Pan-Cancer Retrospective Study on the Relationship Between Tumor Microenvironment Composition and Efficacy of Antibody-Based Antitumor Therapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Antibody; Tumor Microenvironment

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Tianjin Medical University Cancer Institute & Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spearman correlation coefficient between tumor microenvironment marker levels and objective response rate/progression-free survival	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).		January 2020 and January 2026
Subgroup-specific Spearman correlation coefficient between tumor microenvironment marker levels and objective response rate	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	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		January 2020 and January 2026

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PRISM-AB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No