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

2026年5月7日更新者：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.

研究概览

地位

主动，不招人

条件

研究类型

观察性的

注册 (估计的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

中国
- Tianjin Municipality
  - Tianjin、Tianjin Municipality、中国
    - Tianjin Medical University Cancer Institute & Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
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.

团体/队列

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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Spearman correlation coefficient between tumor microenvironment marker levels and objective response rate/progression-free survival 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
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). 大体时间：January 2020 and January 2026		January 2020 and January 2026
Subgroup-specific Spearman correlation coefficient between tumor microenvironment marker levels and objective response rate 大体时间：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 大体时间：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 大体时间：January 2020 and January 2026		January 2020 and January 2026

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tianjin Medical University Cancer Institute and Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月1日

初级完成 (估计的)

2026年6月30日

研究完成 (估计的)

2026年6月30日

研究注册日期

首次提交

2026年4月19日

首先提交符合 QC 标准的

2026年5月7日

首次发布 (实际的)

2026年5月13日

研究记录更新

最后更新发布 (实际的)