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Recruiting Phase 2 NCT06349980

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.

Trial Parameters

Condition Carcinoma, Hepatocellular
Sponsor Shanghai Henlius Biotech
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 117
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-05
Completion 2027-02-10
Interventions
HLX53 (1000mg)HLX53 (2000mg)HLX10

Brief Summary

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.

Eligibility Criteria

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 chemoembolizat

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