Could a daily mineral make liver cancer therapy work better?

NCT ID NCT07793695

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether adding daily oral zinc to standard targeted therapy and immunotherapy helps people with advanced liver cancer. About 60 participants will be randomly assigned to receive the standard treatment alone or with either 20 mg or 30 mg of zinc each day. The main goal is to see if zinc increases the number of people whose tumors shrink or disappear by week 16. Researchers will also track how long the cancer stays controlled, overall survival, and safety, and they will measure zinc and copper levels and immune cell changes in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oral elemental zinc supplementation (zinc gluconate tablets) at 20 mg or 30 mg per day, added to standard targeted therapy plus immunotherapy
What this could lead to
If adding zinc improves tumor shrinkage and survival, it could point to a simple, low-cost way to boost the effects of existing liver cancer treatments.
What could go wrong
This is a small, early-phase trial, so the benefit is uncertain. Zinc may not improve outcomes, and high doses could cause side effects like stomach upset or copper deficiency.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female participants aged 18-75 years who are able to understand the study and voluntarily provide written informed consent. 2. Histologically or cytologically confirmed hepatocellular carcinoma (HCC) that is unresectable, recurrent, or metastatic. 3. Estimated life expectancy of more than 3 months. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5. At least one measurable lesion according to RECIST v1.1. The lesion must not have received prior local therapy; if previously treated locally, there must be documented disease progression, defined as an increase of ≥20% in the sum of diameters from the post-treatment nadir with an absolute increase of ≥5 mm, or the appearance of a new lesion meeting RECIST v1.1 measurability criteria. 6. Child-Pugh class A, score 5-6, with no clinically significant ascites, hepatic encephalopathy, or recent hepatic decompensation. 7. Barcelona Clinic Liver Cancer (BCLC) stage B that is unsuitable for or no longer suitable for local treatment, or BCLC stage C. 8. No prior systemic antitumor therapy for unresectable, recurrent, or metastatic HCC, including immune checkpoint inhibitors, anti-VEGF/VEGFR-targeted therapy, tyrosine kinase inhibitors (TKIs), systemic chemotherapy, or other systemic anticancer agents. Prior local treatments, including surgery, ablation, transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), or radiotherapy, are permitted provided that treatment was completed ≥4 weeks before enrollment and related toxicities have recovered to Grade ≤1 or are considered by the investigator not to interfere with study participation. 9. Planned treatment with targeted therapy plus immunotherapy in accordance with applicable treatment guidelines and clinical practice, with the specific background antitumor regimen determined by the investigator before enrollment. The background regimen should not be changed arbitrarily during the study. 10. If the background treatment regimen includes bevacizumab or another anti-VEGF monoclonal antibody, the participant must undergo upper gastrointestinal endoscopy during screening or have an evaluable endoscopic examination performed within 6 months before screening. Participants with esophagogastric varices requiring treatment may be enrolled only after appropriate management and when the investigator considers the bleeding risk to be adequately controlled. 11. Baseline testing for serum zinc, serum copper, and ceruloplasmin must be completed. 12. Adequate major organ function to receive targeted therapy plus immunotherapy, including: * Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L * Platelet count ≥75 × 10⁹/L * Hemoglobin ≥90 g/L * AST and ALT ≤5 × upper limit of normal (ULN) * Total bilirubin ≤1.5 × ULN, or considered by the investigator to be consistent with Child-Pugh class A and safe for enrollment * Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min * INR ≤1.5, unless the participant is receiving stable anticoagulation therapy and the investigator considers the associated risk to be acceptable. 13. Able to take the study medication orally and willing to comply with study treatment, follow-up visits, imaging assessments, and blood sample collection requirements. 14. Participants of childbearing potential must agree to use effective contraception during the study and for the protocol-specified period after the last dose of study treatment. Exclusion Criteria: 1. Primary liver cancer histology other than predominant HCC, such as intrahepatic cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma, or the presence of another active malignancy requiring systemic treatment. 2. Prior systemic antitumor therapy for unresectable, recurrent, or metastatic HCC. Participants who have previously received PD-1, PD-L1, or CTLA-4 inhibitors, or systemic anti-VEGF/VEGFR therapy, will be excluded. 3. Active autoimmune disease, a history of severe immune-related adverse events, or requirement for systemic immunosuppressive therapy within 14 days before screening. 4. Clinically significant ascites, such as ascites requiring repeated paracentesis, albumin infusion, or showing recent rapid worsening; current or previous hepatic encephalopathy, hepatorenal syndrome, or other clear evidence of hepatic decompensation. 5. Confirmed copper deficiency, Wilson disease, Menkes disease, or other clinically significant disorders of copper metabolism; participants currently receiving zinc salts for the treatment of Wilson disease will be excluded. 6. Use of zinc-containing supplements, multivitamin/mineral preparations, zinc-containing denture adhesives, or other supplements that may significantly affect zinc or copper levels within 14-28 days before screening, if such products cannot be discontinued. 7. Conditions that may significantly affect oral drug absorption or adherence, including persistent vomiting, severe diarrhea, short bowel syndrome, active inflammatory bowel disease, gastrointestinal obstruction, severe dysphagia, or any condition that, in the investigator's judgment, would prevent regular oral administration of the study medication. 8. Known severe hypersensitivity to zinc preparations or any drug used in the background targeted therapy plus immunotherapy regimen. 9. Active severe infection. Participants with HBV DNA positivity accompanied by elevated viral load and ALT and/or AST above the upper limit of normal, with evidence of active hepatic inflammation, will be excluded. Participants who are HBsAg-positive but HBV DNA-negative with normal liver biochemistry will not be excluded solely on the basis of HBV carrier status. 10. Untreated or inadequately treated esophagogastric varices, or other portal hypertension-related lesions considered by the investigator to confer a high bleeding risk; gastrointestinal bleeding, hemoptysis, intracranial hemorrhage, or any other Grade ≥3 bleeding event within 6 months before screening. 11. Uncontrolled hypertension, severe cardiovascular or cerebrovascular disease, recent myocardial infarction, stroke, or pulmonary embolism, severe arrhythmia, NYHA class III-IV heart failure, or any condition that, in the investigator's judgment, would preclude safe treatment with anti-VEGF therapy or a TKI. 12. Major surgery within 28 days before screening, unhealed open wounds, active peptic ulcer disease, high risk of gastrointestinal perforation or fistula, or any condition that may adversely affect the safety of bevacizumab or other anti-VEGF therapy. 13. Uncontrolled central nervous system metastases or leptomeningeal metastases, or symptomatic CNS disease. 14. Pregnancy, breastfeeding, or a positive pregnancy test during screening. 15. Planned use during the study of any antitumor treatment, investigational drug, or nutritional intervention outside the protocol that could interfere with assessment of antitumor efficacy. 16. Any other condition that, in the investigator's judgment, makes the participant unsuitable for study enrollment, including severe psychiatric illness, poor adherence, inability to complete follow-up, drug or alcohol abuse, or a clearly increased safety risk.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

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

    Hefei, Anhui, 230001, China

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