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
Study ID
NCT07793695
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral elemental zinc supplementation, 20 mg/day — DRUG
    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.
  • Oral elemental zinc supplementation, 30 mg/day — DRUG
    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.
  • Standard-of-care targeted therapy plus immunotherapy — DRUG
    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).

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Aug 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Group
    Participants will receive standard-of-care targeted therapy plus immunotherapy without additional zinc supplementation.
  • Experimental: Zinc 20 mg/day Group
    Participants will receive standard-of-care targeted therapy plus immunotherapy together with oral elemental zinc supplementation at a dose of 20 mg/day.
  • Experimental: Zinc 30 mg/day Group
    Participants will receive standard-of-care targeted therapy plus immunotherapy together with oral elemental zinc supplementation at a dose of 30 mg/day.

Primary Outcome Measure

Objective Response Rate at Week 16 [ Time Frame: At Week 16 after initiation of study treatment ]

Central Contacts

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