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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined with Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. (NCT06349980) is a Phase 2 interventional studying Carcinoma, Hepatocellular, sponsored by Shanghai Henlius Biotech. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Carcinoma, Hepatocellular and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 117 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Carcinoma, Hepatocellular subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Volunteer to participate in clinical research;To fully understand and understand this study and to sign the willing to sign a consent form Form (ICF);Willing to follow and able to complete all test procedures 2. The age of signing ICF is ≥ 18 years old 3. For patients with cirrhosis, clinical diagnosis is conducted through the American Association for the Study of Liver Diseases (AASLD) standards, while non-cirrhotic patients require a diagnosis confirmed by histological examination. 4. No prior systemic treatment for HCC. 5. Barcelona Clinic Liver Cancer (BCLC) stage C; BCLC stage B patients who are not suitable for locoregional therapy may also be enrolled. 6. Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST v1.1 criteria. The measurable target lesion should not have undergone any prior local treatment (such as radiotherapy, radiofrequency ablation, transarterial chemoembolization (TACE), high-intensity focused ultrasound (HIFU), etc.). A region that has received prior local treatment may also be selected as a target lesion if there is a clear progression that meets the RECIST v1.1 standards. 7. Tumor tissue required for an evaluable PD-L1 expression result at Screening period, if available 8. Palliative radiotherapy for bone metastatic lesions was initiated at least 2 weeks prior to the first administration and ≥4 weeks have elapsed since the last therapy; diagnostic liver biopsy was performed at least 1 week prior to the first administration of the medication in this study. Previous local treatment-related AEs have resolved to an NCI-CTCAE grade of ≤ 1. 9. Child-pugh liver function rating within 7 days before the first administration of the study drug : grade A and good grade B (≤ 7 points). 10. The ECOG physical performance score within 7 days before the first administration of the study drug was 0 or 1. 11. Expected survival ≥ 12 weeks. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Volunteer to participate in clinical research;To fully understand and understand this study and to sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures 2. The age of signing ICF is ≥ 18 years old 3. For patients with cirrhosis, clinical diagnosis is conducted through the American Association for the Study of Liver Diseases (AASLD) standards, while non-cirrhotic patients require a diagnosis confirmed by histological examination. 4. No prior systemic treatment for HCC. 5. Barcelona Clinic Liver Cancer (BCLC) stage C; BCLC stage B patients who are not suitable for locoregional therapy may also be enrolled. 6. Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST v1.1 criteria. The measurable target lesion should not have undergone any prior local treatment (such as radiotherapy, radiofrequency ablation, transarterial chemoembolization (TACE), high-intensity focused ultrasound (HIFU), etc.). A region that has received prior local treatment may also be selected as a target lesion if there is a clear progression that meets the RECIST v1.1 standards. 7. Tumor tissue required for an evaluable PD-L1 expression result at Screening period, if available 8. Palliative radiotherapy for bone metastatic lesions was initiated at least 2 weeks prior to the first administration and ≥4 weeks have elapsed since the last therapy; diagnostic liver biopsy was performed at least 1 week prior to the first administration of the medication in this study. Previous local treatment-related AEs have resolved to an NCI-CTCAE grade of ≤ 1. 9. Child-pugh liver function rating within 7 days before the first administration of the study drug : grade A and good grade B (≤ 7 points). 10. The ECOG physical performance score within 7 days before the first administration of the study drug was 0 or 1. 11. Expected survival ≥ 12 weeks. 12. Adequate hematologic and end-organ function. Exclusion Criteria: 1. Hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma are known. 2. History of hepatic encephalopathy or has undergone a liver transplant. Patients who are preparing for or have previously undergone organ or bone marrow transplantation. 3. Within 6 months prior to the first administration of treatment, present with portal hypertension accompanied by upper gastrointestinal bleeding, or have esophageal/gastric varices with red wale markings, or are at risk of ruptured hemorrhagic hepatic cancer nodules, or are considered by the researcher to be at high risk of bleeding. 4. According to the images, portal vein invasion, inferior vena cava or cardiac involvement of HCC main portal branch (Vp4) were present. Patients with cancer thrombus in main portal vein but smooth blood flow in contralateral branch can be enrolled. 5. Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases. 6. History of any second primary malignancy within 2 years prior to the first administration of the drug, excluding early-stage malignancies that have been treated curatively (carcinoma in situ or stage I tumors), such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, breast ductal carcinoma in situ, and papillary thyroid carcinoma. 7. After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently (once a month or more frequently). 8. Human immunodeficiency virus (HIV) infection. 9. Active tuberculosis. 10. Patients with previous and current cases of interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impairment of lung function that may interfere with the detection and management of suspected drug-related lung toxicity. 11. Active or suspected autoimmune disease. Patients with autoimmune-related hypothyroidism who are undergoing thyroid hormone replacement therapy are permitted to participate in the study; patients with controlled Type 1 diabetes mellitus receiving insulin therapy are also allowed to participate in the study. 12. Within 14 days prior to the first administration of the study drug, any active infection requiring systematic anti-infective treatment occurs. 13. Manifestations of bleeding (including hemoptysis, abnormal vaginal bleeding, etc.) during screening period, or Grade 2 bleeding events within 3 months before signing the informed consent form, and Grade 3 or higher bleeding events within the past 6 months. 14. Known history of severe allergies to any monoclonal antibodies or excipients used in the study medication. 15. Previous treatment with any T cell co-stimulation or immune checkpoint therapy (e.g., CTLA-4, PD-1 inhibitors, PD-L1/2 inhibitors, etc.), or previous treatment with bevacizumab or its biosimilars, or previous treatment with anti-TIGIT therapy or related targets (such as CD155, CD112, or CD113 antibodies, etc.). 16. The researcher deems that the subject has any other factors that make them unsuitable for participation in this trial.

Treatments Being Tested

DRUG

HLX53 (1000mg)

HLX53 will be administered by IV infusion at a fixed dose of 1000 mg on Day 1 of each 21-day cycle.

DRUG

HLX53 (2000mg)

HLX53 will be administered by IV infusion at a fixed dose of 2000 mg on Day 1 of each 21-day cycle.

DRUG

HLX10

HLX10 will be administered by IV infusion at a fixed dose of 300 mg on Day 1 of each 21-day cycle.

DRUG

HLX04

HLX04 will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

OTHER

Placebo

Placebo matching HLX53 will be administered by IV infusion on Day 1 of each 21-day cycle.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Zhongshan Hospital, Fudan University
Shanghai, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06349980), the sponsor (Shanghai Henlius Biotech), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06349980 clinical trial studying?

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06349980?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06349980?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06349980. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06349980. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.