# 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.

Source: https://onco.cc/trials/nct06349980/  
OnCo record `nct06349980` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Serplulimab in hepatocellular carcinoma, run by Shanghai Henlius Biotech, now recruiting.

## Summary

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. is a phase 2 interventional study registered as NCT06349980 by Shanghai Henlius Biotech, with 117 participants planned, started 2024-08-05 and due to reach its primary completion in 2027-02-10. Interventions recorded: HLX53 (1000mg), HLX53 (2000mg), HLX10 and HLX04.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT06349980
- Phase: 2
- Setting: 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.
- Sponsor: Shanghai Henlius Biotech
- Enrolled: 117

## Sources

- ClinicalTrials.gov NCT06349980: https://clinicaltrials.gov/study/NCT06349980

## Connected records

- cancers: [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/)
- drugs: [Serplulimab](https://onco.cc/drugs/serplulimab/)
- companies: [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/)

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