OncoMatch/Clinical Trials/NCT07793695
Oral Zinc Supplementation Combined With Targeted Immunotherapy for Unresectable or Advanced Hepatocellular Carcinoma
Official title: A Randomized Controlled Trial Evaluating Different Doses of Oral Zinc Supplementation in Combination With Targeted Immunotherapy for Unresectable or Advanced Hepatocellular Carcinoma
Is NCT07793695 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Oral elemental zinc supplementation, 20 mg/day and Oral elemental zinc supplementation, 30 mg/day for hepatocellular carcinoma.
Treatment: Oral elemental zinc supplementation, 20 mg/day · Oral elemental zinc supplementation, 30 mg/day · Standard-of-care targeted therapy plus immunotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage IV, BCLC STAGE B THAT IS UNSUITABLE FOR OR NO LONGER SUITABLE FOR LOCAL TREATMENT, BCLC STAGE C (other)
unresectable, recurrent, or metastatic; BCLC stage B that is unsuitable for or no longer suitable for local treatment, or BCLC stage C
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic antitumor therapy for unresectable, recurrent, or metastatic HCC
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
Cannot have received: local antitumor treatment (surgery, ablation, transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiotherapy)
Participants must not have received any prior local antitumor treatment, including surgery, ablation, transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), or radiotherapy
Cannot have received: systemic antitumor therapy for unresectable, recurrent, or metastatic HCC (PD-1 inhibitor, PD-L1 inhibitor, CTLA-4 inhibitor, systemic anti-VEGF/VEGFR therapy)
Participants who have previously received PD-1, PD-L1, or CTLA-4 inhibitors, or systemic anti-VEGF/VEGFR therapy, will be excluded
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Platelet count ≥75 × 10⁹/L; Hemoglobin ≥90 g/L
Kidney function
Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min
Liver function
Child-Pugh class A, score 5-6, with no clinically significant ascites, hepatic encephalopathy, or recent hepatic decompensation; AST and ALT ≤5 × ULN; Total bilirubin ≤1.5 × ULN, or considered by the investigator to be consistent with Child-Pugh class A and safe for enrollment
Adequate major organ function to receive targeted therapy plus immunotherapy, including: ANC ≥1.5 × 10⁹/L; Platelet count ≥75 × 10⁹/L; Hemoglobin ≥90 g/L; AST and ALT ≤5 × 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07793695 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage IV or BCLC STAGE B THAT IS UNSUITABLE FOR OR NO LONGER SUITABLE FOR LOCAL TREATMENT or BCLC STAGE C is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages