Hepatocellular CarcinomaPhase 2ZINC-1LT/IOHCCNCT07793695
Oral Zinc Supplementation Combined With Targeted Immunotherapy for Unresectable or Advanced Hepatocellular Carcinoma
A Phase 2 study testing Oral elemental zinc supplementation, 20 mg/day, Oral elemental zinc supplementation, 30 mg/day and Standard-of-care targeted therapy plus immunotherapy in people with Hepatocellular Carcinoma, run by Anhui Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Oral elemental zinc supplementation, 20 mg/day, Oral elemental zinc supplementation, 30 mg/day and Standard-of-care targeted therapy plus immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18-75 years who are able to understand the study and voluntarily provide written informed consent.
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC) that is unresectable, recurrent, or metastatic.
- Estimated life expectancy of more than 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- At least one measurable lesion as defined by RECIST v1.1, with no prior local treatment to the measurable lesion.
- Child-Pugh class A, score 5-6, with no clinically significant ascites, hepatic encephalopathy, or recent hepatic decompensation.
Show all 22Show fewer
- Barcelona Clinic Liver Cancer (BCLC) stage B that is unsuitable for or no longer suitable for local treatment, or BCLC stage C.
- 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.
- Participants must not have received any prior local antitumor treatment, including surgery, ablation, transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), or radiotherapy.
- 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.
- 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.
- Baseline testing for serum zinc, serum copper, and ceruloplasmin must be completed.
- 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.
- Able to take the study medication orally and willing to comply with study treatment, follow-up visits, imaging assessments, and blood sample collection requirements.
- 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.
Who cannot join
- 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.
- 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.
- Active autoimmune disease, a history of severe immune-related adverse events, or requirement for systemic immunosuppressive therapy within 14 days before screening.
- 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.
- 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.
- 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.
Show all 16Show fewer
- 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.
- Known severe hypersensitivity to zinc preparations or any drug used in the background targeted therapy plus immunotherapy regimen.
- 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.
- 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.
- 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.
- 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.
- Uncontrolled central nervous system metastases or leptomeningeal metastases, or symptomatic CNS disease.
- Pregnancy, breastfeeding, or a positive pregnancy test during screening.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hua Lu, MD contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 230001
Yao Liu, Prof, 0551-62284121, liuyao66@ustc.edu.cn
About this study
Official title: A Randomized Controlled Trial Evaluating Different Doses of Oral Zinc Supplementation in Combination With Targeted Immunotherapy for Unresectable or Advanced Hepatocellular Carcinoma
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.
Read more
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Oral elemental zinc supplementation, 20 mg/day, Oral elemental zinc supplementation, 30 mg/day, Standard-of-care targeted therapy plus immunotherapy
- Keywords
- Hepatocellular carcinoma, Targeted therapy plus immunotherapy, Zinc supplementation, Objective response rate
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral elemental zinc supplementation, 20 mg/dayDrug
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/dayDrug
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 immunotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants will receive standard-of-care targeted therapy plus immunotherapy without additional zinc supplementation. Receives: Drug: Standard-of-care targeted therapy plus immunotherapy |
| Zinc 20 mg/day Group | Experimental | Participants will receive standard-of-care targeted therapy plus immunotherapy together with oral elemental zinc supplementation at a dose of 20 mg/day. Receives: Drug: Oral elemental zinc supplementation, 20 mg/day; Drug: Standard-of-care targeted therapy plus immunotherapy |
| Zinc 30 mg/day Group | Experimental | Participants will receive standard-of-care targeted therapy plus immunotherapy together with oral elemental zinc supplementation at a dose of 30 mg/day. Receives: Drug: Oral elemental zinc supplementation, 30 mg/day; Drug: Standard-of-care targeted therapy plus immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) at Week 18
Proportion of participants achieving complete response (CR) or partial response (PR) at Week 18 according to RECIST v1.1. ORR = (CR + PR) / total number of participants in the analysis set × 100%.
Measured: At Week 18 after initiation of study treatment
Secondary outcomes (11)
Objective Response Rate (ORR) at Week 9
Proportion of participants achieving complete response (CR) or partial response (PR) at Week 9 according to RECIST v1.1.
Measured: At Week 9 after initiation of study treatment.
Objective Response Rate (ORR) by mRECIST
Proportion of participants achieving complete response (CR) or partial response (PR) according to mRECIST for hepatocellular carcinoma.
Measured: At Weeks 9 and 18 after initiation of study treatment.
Disease Control Rate
Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD), assessed according to RECIST v1.1 and mRECIST.
Measured: At Weeks 9 and 18 after initiation of study treatment.
Progression-Free Survival
Time from enrollment to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Measured: From enrollment until disease progression or death, whichever occurs first.
Overall Survival
Time from enrollment to death from any cause. Participants who are alive will be censored at the date of last known survival.
Measured: From enrollment until death from any cause.
Change in Serum Zinc Level
Absolute and relative changes in serum zinc levels from baseline.
Measured: At Weeks 3, 6, 9,12,15 and 18 after initiation of study treatment.
Incidence of Copper Deficiency
Proportion of participants with serum copper or ceruloplasmin levels below the lower limit of normal during treatment.
Measured: At Weeks 3, 6, 9,12,15 and 18 after initiation of study treatment.
Zinc Correction Rate
Proportion of participants with baseline serum zinc <80 μg/dL who achieve a serum zinc level ≥80 μg/dL at the specified visit.
Measured: At Weeks 3, 6, 9,12,15 and 18 after initiation of study treatment.
Change in Peripheral Blood CD3+, CD4+, and CD8+ T-cell Counts
Change from baseline in the absolute counts of peripheral blood CD3+, CD4+, and CD8+ T cells, measured by flow cytometry.
Measured: At Weeks 3, 6, 9,12,15 and 18 after initiation of study treatment.
Change in Ki-67+ Cells Among Peripheral Blood PD-1+CD8+ T Cells
Change from baseline in the proportion of Ki-67+ cells among peripheral blood PD-1+CD8+ T cells, measured by flow cytometry.
Measured: At Weeks 3, 6, 9,12,15 and 18 after initiation of study treatment.
Fold Change in Ki-67+ Cells Among Peripheral Blood PD-1+CD8+ T Cells
Fold change from baseline in the proportion of Ki-67+ cells among peripheral blood PD-1+CD8+ T cells at Week 3, measured by flow cytometry. A fold change of 2.8 or greater will be explored as an early immune response threshold.
Measured: At Week 3 after initiation of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start16 Sep 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lianxin Liu, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793695
- Sponsor's protocol ID
- 2026KY1085
- Acronym
- ZINC-1LT/IOHCC
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating Different Doses of Oral Zinc Supplementation in Combination With Targeted Immunotherapy for Unresectable or Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07793695
- Acronym / sponsor ID
- ZINC-1LT/IOHCC / 2026KY1085
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Targeted therapy plus immunotherapy, Zinc supplementation, Objective response rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 16 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Standard-of-care targeted therapy plus immunotherapyParticipants will receive standard-of-care targeted therapy plus immunotherapy without additional zinc supplementation. |
| Zinc 20 mg/day Group | Experimental | Drug: Oral elemental zinc supplementation, 20 mg/day, Drug: Standard-of-care targeted therapy plus immunotherapyParticipants will receive standard-of-care targeted therapy plus immunotherapy together with oral elemental zinc supplementation at a dose of 20 mg/day. |
| Zinc 30 mg/day Group | Experimental | Drug: Oral elemental zinc supplementation, 30 mg/day, Drug: Standard-of-care targeted therapy plus immunotherapyParticipants will receive standard-of-care targeted therapy plus immunotherapy together with oral elemental zinc supplementation at a dose of 30 mg/day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female participants aged 18-75 years who are able to understand the study and voluntarily provide written informed consent.
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC) that is unresectable, recurrent, or metastatic.
- Estimated life expectancy of more than 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- At least one measurable lesion as defined by RECIST v1.1, with no prior local treatment to the measurable lesion.
Key exclusion criteria (16 listed)
- 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.
- 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.
- Active autoimmune disease, a history of severe immune-related adverse events, or requirement for systemic immunosuppressive therapy within 14 days before screening.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral elemental zinc supplementation, 20 mg/dayParticipants 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 | Zinc 20 mg/day Group |
| Oral elemental zinc supplementation, 30 mg/dayParticipants 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 | Zinc 30 mg/day Group |
| Standard-of-care targeted therapy plus immunotherapyThe 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. | Drug | Control Group, Zinc 20 mg/day Group, Zinc 30 mg/day Group |
Primary outcome
Objective Response Rate (ORR) at Week 18
Time frame: At Week 18 after initiation of study treatment
Proportion of participants achieving complete response (CR) or partial response (PR) at Week 18 according to RECIST v1.1. ORR = (CR + PR) / total number of participants in the analysis set × 100%.
11 secondary outcomes
Objective Response Rate (ORR) at Week 9
Time frame: At Week 9 after initiation of study treatment.
Objective Response Rate (ORR) by mRECIST
Time frame: At Weeks 9 and 18 after initiation of study treatment.
Disease Control Rate
Time frame: At Weeks 9 and 18 after initiation of study treatment.
Progression-Free Survival
Time frame: From enrollment until disease progression or death, whichever occurs first.
Overall Survival
Time frame: From enrollment until death from any cause.
Change in Serum Zinc Level
Time frame: At Weeks 3, 6, 9,12,15 and 18 after initiation of study treatment.
Incidence of Copper Deficiency
Time frame: At Weeks 3, 6, 9,12,15 and 18 after initiation of study treatment.
Zinc Correction Rate
Time frame: At Weeks 3, 6, 9,12,15 and 18 after initiation of study treatment.
Change in Peripheral Blood CD3+, CD4+, and CD8+ T-cell Counts
Time frame: At Weeks 3, 6, 9,12,15 and 18 after initiation of study treatment.
Change in Ki-67+ Cells Among Peripheral Blood PD-1+CD8+ T Cells
Time frame: At Weeks 3, 6, 9,12,15 and 18 after initiation of study treatment.
Fold Change in Ki-67+ Cells Among Peripheral Blood PD-1+CD8+ T Cells
Time frame: At Week 3 after initiation of study treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hua Lu, MD contact
Lianxin Liu principal investigator
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral elemental zinc supplementation, 20 mg/day, Oral elemental zinc supplementation, 30 mg/day and Standard-of-care targeted therapy plus immunotherapy in people with Hepatocellular Carcinoma, run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Liu, Dr (0551-62284121, liuyao66@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) at Week 18 (time frame: At Week 18 after initiation of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.