Galectin-3 levels and outcomes with PD-1/PD-L1 therapy in kidney, bladder, lung, and liver cancer
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
This study tests whether blood galectin‑3 levels before treatment predict outcomes for people with kidney, bladder, lung, or liver cancer who are starting PD‑1/PD‑L1 immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Tel Aviv, Israel) |
| Trial ID | NCT07485114 on ClinicalTrials.gov |
What this trial studies
This observational study will measure baseline serum galectin‑3, routine blood counts, and chemistry including liver function in patients with renal cell, transitional cell, non‑small cell lung, or hepatocellular carcinoma who are about to begin PD‑1/PD‑L1 inhibitors. Patients will be followed while receiving standard-of-care immunotherapy to record clinical outcomes and immune‑related side effects. The goal is to correlate pre-treatment galectin‑3 levels with treatment response, progression, and toxicity. No investigational drugs are given; all treatments follow normal clinical practice and the study only collects blood and safety data.
Who should consider this trial
Good fit: Adults (aged 18 or older) with renal cell carcinoma, transitional cell carcinoma, non‑small cell lung cancer, or hepatocellular carcinoma who are scheduled to start PD‑1/PD‑L1 therapy and can give informed consent are eligible.
Not a fit: People not receiving PD‑1/PD‑L1 therapy, those already past their first treatment cycle, or pregnant/lactating individuals are unlikely to benefit from participating in this observational biomarker study.
Why it matters
Potential benefit: If successful, a simple blood test for galectin‑3 could help identify who is more likely to benefit from PD‑1/PD‑L1 drugs and who may be at higher risk for side effects.
How similar studies have performed: Preclinical work and small clinical reports link galectin‑3 to PD‑L1 expression and immune resistance, but using baseline serum galectin‑3 as a predictive biomarker for immunotherapy response remains relatively novel and not yet widely validated.
Eligibility criteria
Show full 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.
Where this trial is running
Tel Aviv, Israel
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel, Israel (Recruiting)
Study contacts
- Study coordinator: Daniel Keizman, MD
- Email: danielke@tlvmc.gov.il
- Phone: 972-3-6947832
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.