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

NCT07485114 | Recruiting

• 1 other identifier: 0578-24
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.
• Study enrollment and withdrawal: Inclusion/Exclusion Criteria:
• Must be able to read and understand the informed consent form (ICF) and follow protocol requirements
• Patients aged\>=18 years
• Patients with renal cell carcinoma, Transitional cell carcinoma, non small cell lung cancer, and hepatocellular carcinoma
• Patients treated with PD-1/PDL-1 inhibitors
• Patients prior to first cycle of PD-1/PDL-1 inhibitors
• Subjects willing to continue and take part in the study for the throughout the study duration.
• 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.
• 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.
• 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.
• Gal-3 blood levels: collected of 3 ml before every immunotherapy administration per treatment
• 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• Gal-3 blood level withdrawn of 3 ml each visit before each treatment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.
• Statistical analysis: Upon trial completion, the possible correlation between Gal-3 levels and immunotherapy outcomes will be analyzed.

Conditions

Renal Cell Carcinoma (Kidney Cancer); Non Small Cell Lung Cancer; Hepatocellular Carcinoma; Transitional Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• To correlate Gal-3 levels with patient outcomes, including response to treatment, duration of response, survival, and side effects observed.

  3 years

Secondary Outcomes (1)

• To monitor and analyze serum Gal-3 level & fluctuations over the course of PD-1/PDL-1 inhibitors in oncological patients.

  3 years

Interventions

Serum Gal-3 level, blood count and chemistry included liver function DIAGNOSTIC_TEST

Blood tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Daniel Keizman: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239, Israel

RECRUITING

Related Links

• Galectin-3 and cancer immunotherapy: a glycobiological rationale to overcome tumor immune escape. Scafetta G, et al,A.J Exp Clin Cancer Res. 2024
• Predictive Biomarkers for Checkpoint Inhibitor-Based Immunotherapy: The Galectin-3 Signature in NSCLCs.. Capalbo C et al, A.Int J Mol Sci. 2019
• Inhibition of galectin-3 augments the antitumor efficacy of PD-L1 blockade in non-small-cell lung cancer. Zhang H et al, FEBS Open Bio. 2021

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood count, chemistry, liver function, 2. Gal-3 blood levels

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Hepatocellular; Carcinoma, Transitional Cell

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Daniel Keizman, MD

CONTACT

972-3-6947832; danielke@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 3, 2028
• Study Completion (Estimated): December 3, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)