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

Study acronym: ZINC-1LT/IOHCC
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Anhui Provincial Hospital

Record History

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  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Recruitment opened
    • Start date: Sep 1, 2026 to Sep 16, 2026
    • Interventions: Oral elemental zinc supplementation, 20 mg/day (Drug), Oral elemental zinc supplementation, 30 mg/day (Drug), Standard-of-care targeted… to Oral elemental zinc supplementation, 20 mg/day (Drug), Oral elemental zinc supplementation, 30 mg/day (Drug), Standard-of-care targeted…
    • Eligibility criteria shortened, about 29 words
    • Secondary endpoints revised (11)
    • Site details revised
    • Study title shortened, about 9 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07793695
Lead Sponsor Anhui Provincial Hospital
Conditions
(from sponsor)		 Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov