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.

NCT Number	NCT07584044
Lead Sponsor	Tianjin Medical University Cancer Institute and Hospital
Conditions	Tumor Microenvironment, Antibody
Enrollment	300 participants
Start Date	2026-03-01
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-13