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

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 16. 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.

Conditions

• Hepatocellular Carcinoma

Interventions

DRUG

Oral 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.

DRUG

Oral 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.

DRUG

Standard-of-care targeted therapy plus immunotherapy

The background targeted therapy plus immunotherapy regimen will be determined by the investigator based on the participant's clinical condition, applicable treatment guidelines, prescribing information, and routine clinical practice at the study center. Permitted regimens include sintilimab plus bevacizumab or a bevacizumab biosimilar, tislelizumab plus lenvatinib, and atezolizumab plus bevacizumab. The background treatment regimen should remain unchanged during the study whenever clinically feasible. If treatment modification is required because of toxicity, intolerance, disease progression, drug availability, or other clinical considerations, the reason for and details of the modification will be documented in the case report form (CRF).

Sponsors & Collaborators

• Anhui Provincial Hospital

  lead OTHER_GOV

Principal Investigators

• Lianxin Liu · The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-08-01

Completion

2027-12-31

Countries

• China

Study Locations