Galectin-3 levels and outcomes with PD-1/PD-L1 therapy in kidney, bladder, lung, and liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.