RecruitingPhase 2NCT07793695

Oral Zinc Supplementation Combined With Targeted Immunotherapy for Unresectable or Advanced Hepatocellular Carcinoma

A Randomized Controlled Trial Evaluating Different Doses of Oral Zinc Supplementation in Combination With Targeted Immunotherapy for Unresectable or Advanced Hepatocellular Carcinoma


Sponsor

Anhui Provincial Hospital

Enrollment

60 participants

Start Date

Sep 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study will look at whether adding daily oral zinc supplements to targeted therapy plus immunotherapy may help people with unresectable or advanced hepatocellular carcinoma, a common type of liver cancer. About 60 participants will take part in this study. Participants will be randomly assigned to one of three groups. One group will receive targeted therapy plus immunotherapy without extra zinc. The other two groups will receive the same type of cancer treatment together with either 20 mg or 30 mg of elemental zinc each day. The main goal is to compare how many participants have their tumors shrink or disappear by Week 18. Researchers will also look at tumor response at earlier time points, how long the cancer remains under control, overall survival, and treatment safety. Blood tests will be used to measure zinc and copper levels during the study. Researchers will also study changes in immune cells, including T cells, to better understand whether zinc supplementation may affect the body's immune response to cancer treatment. This study is designed to explore whether oral zinc supplementation is safe and may improve the effects of targeted therapy plus immunotherapy. The results may help determine which zinc dose should be studied in larger clinical trials.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Oral elemental zinc supplementation, 20 mg/day, a drug called Oral elemental zinc supplementation, 30 mg/day, and others for people with hepatocellular carcinoma. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral elemental zinc supplementation, 20 mg/day

Participants will receive oral elemental zinc supplementation at a dose of 20 mg/day. Zinc gluconate tablets will be administered orally, 1 tablet twice daily after meals.

DRUGOral elemental zinc supplementation, 30 mg/day

Participants will receive oral elemental zinc supplementation at a dose of 30 mg/day. Zinc gluconate tablets will be administered orally, 1 tablet three times daily after meals.

DRUGStandard-of-care targeted therapy plus immunotherapy

The background targeted therapy plus immunotherapy regimen will be selected by the investigator based on the participant's clinical condition and standard clinical practice. Permitted regimens include atezolizumab plus bevacizumab and camrelizumab plus apatinib.


Locations(1)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

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NCT07793695


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