Tumor MicroenvironmentNCT07584044
A Pan-Cancer Retrospective Study on the Relationship Between Tumor Microenvironment Composition and Efficacy of Antibody-Based Antitumor Therapy
An observational study of Tumor Microenvironment and Antibody, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Microenvironment, Antibody
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
About this study
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.
- Conditions
- Tumor Microenvironment, Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 2020 and January 2026
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: January 2020 and January 2026
To construct a multivariable predictive model or risk stratification tool where feasible
Measured: January 2020 and January 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Mar 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor MicroenvironmentStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584044
- Sponsor's protocol ID
- PRISM-AB
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pan-Cancer Retrospective Study on the Relationship Between Tumor Microenvironment Composition and Efficacy of Antibody-Based Antitumor Therapy
- ClinicalTrials.gov ID
- NCT07584044
- Acronym / sponsor ID
- PRISM-AB
- Conditions
- Tumor Microenvironment, Antibody
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spearman correlation coefficient between tumor microenvironment marker levels and objective response rate/progression-free survival
Time frame: 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.
4 secondary outcomes
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).
Time frame: January 2020 and January 2026
Subgroup-specific Spearman correlation coefficient between tumor microenvironment marker levels and objective response rate
Time frame: January 2020 and January 2026
Interaction term odds ratio for clinical factors modifying the association between tumor microenvironment marker levels and objective response
Time frame: January 2020 and January 2026
To construct a multivariable predictive model or risk stratification tool where feasible
Time frame: January 2020 and January 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor Microenvironment and Antibody, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spearman correlation coefficient between tumor microenvironment marker levels and objective response rate/progression-free survival (time frame: January 2020 and January 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.