Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

March 16, 2026 updated by: Daniel Keizman

  1. Background and Rationale::

    Galectin-3 (Gal-3) is a β-galactoside-binding protein involved in various biological processes, including cell proliferation, apoptosis, adhesion, and immune regulation. In cancer, Gal-3 promotes tumor progression by enhancing cell survival, metastasis, and angiogenesis. Additionally, Gal-3 can upregulate Programmed Death-Ligand 1 (PDL-1) expression on cancer cells, contributing to immune evasion. PDL-1, an immune checkpoint protein, binds to its receptor PD-1 on T cells, inhibiting their activity and allowing cancer cells to escape immune detection. The interaction between Gal-3 and PDL-1 creates an immunosuppressive tumor microenvironment, reducing the efficacy of PDL-1 inhibitor therapies. Gal-3 drives the inflammatory response and can worsen the inflammation based side effects of PD-1/PDL-1 inhibitos. Understanding this interplay is crucial for optimizing treatments and improving patient outcomes in cancer immunotherapy.

    The present study employs the FDA-approved, automated Architect system, initially used in cardiology, to ensure high accuracy and consistency in Gal-3 measurement. This method represents a significant advance over traditional manual ELISA kits, aiming to standardize and reproduce results across the patient cohort and to optimize the application of XGAL-3 apheresis based on robust data. The study results can help optimize the use of the XGAL-3 therapeutic apheresis as an adjuvant treatment to enhance the efficacy and reduce the side effects associated with PDL-1 inhibitors.

    Therefore, the aim of this study is to conduct an observational clinical trial assessing the correlation between Galectin-3 Level and immunotherapy Outcomes in renal cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma patients treated with PD-1/ PDL-1 Inhibitors

  2. Study Objectives:

    • Primary objectives: To correlate Gal-3 levels with patient outcomes, including response to treatment, duration of response, survival, and side effects observed.
    • Secondary objectives: To monitor and analyze serum Gal-3 level & fluctuations over the course of PD-1/PDL-1 inhibitors in oncological patients.
  3. Study enrollment and withdrawal: Inclusion/Exclusion Criteria:

Inclusion Criteria:

  1. Must be able to read and understand the informed consent form (ICF) and follow protocol requirements
  2. Patients aged>=18 years
  3. Patients with renal cell carcinoma, Transitional cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma
  4. Patients treated with PD-1/PDL-1 inhibitors
  5. Patients prior to first cycle of PD-1/PDL-1 inhibitors
  6. Subjects willing to continue and take part in the study for the throughout the study duration.

Exclusion Criteria :

  1. Female subject who is pregnant, lactating, or who want to get pregnant during the study period. Male subjects who want their partner to get pregnant.
  2. Female of child-bearing potential who can't agree to utilize medically acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study.

4. Study Design and Methodology: Study population: Oncology patients with renal cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma, receiving PD-1/PDL-1 inhibitors Study duration: 3 years Number of patients: 300 patients Study type: This is a prospective, observational. study evaluating the correlation between serum Gal-3 level & fluctuations and treatment outcome of immunotherapy based PD-1/PDL-1 inhibitors in patients with renal cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma General Study design: The study will enroll participants from the Tel Aviv Sourasky medical center who are diagnosed with renal cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma, and treated with PD-1/PDL-1 based immunotherapy Methodology

  1. Data Collection: clinical and laboratory data will be collected before treatment, including blood count and chemistry included liver function In addition, disease characteristics , demographic data (age, sex), treatment-related information (concomitant medications, dosages), and documentation of adverse events will be recorded each evaluation. All data will be entered into the CRF in accordance with study procedures.
  2. Gal-3 blood levels: collected of 3 ml before every immunotherapy administration per treatment

  3. Gal-3 blood levels testing method

    • Gal-3 blood level withdrawn of 3 ml each visit before each treatment
    • Samples will be frozen at -80°C microbiology lab and analyzed in pre-determined group size or periodical testing.
    • Utilize the ARCHITECT platform for all testing, with reagents supplied by Eliaz Therapeutics Inc, ensuring consistency and reliability in test results.
  4. Statistical analysis: Upon trial completion, the possible correlation between Gal-3 levels and immunotherapy outcomes will be analyzed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
    • Israel
      • Tel Aviv, Israel, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Principal Investigator:
          • Daniel Keizman, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Renal Cell Carcinoma, Urinary cancer , Non small cell lung cancer, and hepatocellular carcinoma, treated with PD-1/PDL-1 Inhibitors

Description

Inclusion Criteria:

  1. Must be able to read and understand the informed consent form (ICF) and follow protocol requirements
  2. Patients aged>=18 years
  3. Patients with renal cell carcinoma, Transitional cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma
  4. Patients treated with PD-1/PDL-1 inhibitors
  5. Patients prior to first cycle of PD-1/PDL-1 inhibitors
  6. Subjects willing to continue and take part in the study for the throughout the study duration.

Exclusion Criteria:

  1. Female subject who is pregnant, lactating, or who want to get pregnant during the study period. Male subjects who want their partner to get pregnant.
  2. Female of child-bearing potential who can't agree to utilize medically acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To correlate Gal-3 levels with patient outcomes, including response to treatment, duration of response, survival, and side effects observed.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To monitor and analyze serum Gal-3 level & fluctuations over the course of PD-1/PDL-1 inhibitors in oncological patients.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Keizman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2025

Primary Completion (Estimated)

December 3, 2028

Study Completion (Estimated)

December 3, 2028

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0578-24

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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