NCT04465734 is a Phase 3 clinical trial of HLX10 in Hepatocellular Carcinoma (HCC), sponsored by Shanghai Henlius Biotech.

Who is sponsoring NCT04465734?

NCT04465734 is sponsored by Shanghai Henlius Biotech.

What drugs are being tested in NCT04465734?

Interventions in NCT04465734: HLX10, HLX04, Sorafenib.

What condition does NCT04465734 study?

NCT04465734 studies Hepatocellular Carcinoma (HCC).

Is NCT04465734 still recruiting?

NCT04465734 is currently withdrawn. Last updated 5 May 2022.

Last reviewed 2022-05-05 · How we verify

NCT04465734

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC

Withdrawn Phase 3 Last updated 5 May 2022

What this trial tests

Phase 3 trial testing HLX10 in Hepatocellular Carcinoma (HCC). Withdrawn.

Timeline

15 November 2022

Primary endpoint
15 October 2023

15 March 2024

Quick facts

Lead sponsor	Shanghai Henlius Biotech
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	15 November 2022
Primary completion	15 October 2023
Estimated completion	15 March 2024
Sites	1 location across China

Drugs / interventions tested

HLX10 — full drug profile →
HLX04 — full drug profile →
Sorafenib (SORAFENIB) — full drug profile →

Conditions studied

Hepatocellular Carcinoma (HCC) — all drugs for Hepatocellular Carcinoma (HCC) →

Sponsor

Shanghai Henlius Biotech — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatocellular Carcinoma (HCC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the efficacy and safety of HLX10 + HLX04 vs Sorafenibas as the First-line Treatment in Patients with Locally Advanced or Metastatic HCC Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows: Arm A (treatment group): HLX10 + HLX04 Arm B (control group): sorafenib Randomization is stratified by: region (Asia (excluding Japan) vs. others), HBV infection vs. HCV infection vs. no HBV or HCV infection, portal vein invasion or/and extrahepatic spread (with vs.without), and ECOG (0 vs. 1).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging Therapies for Hepatocellular Carcinoma (HCC).
Chakraborty E, Sarkar D. · · 2022 · cited 236× · PMID 35681776 · DOI 10.3390/cancers14112798
Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets.
Luo XY, Wu KM, He XX. · · 2021 · cited 144× · PMID 34006331 · DOI 10.1186/s13046-021-01968-w
Old Player-New Tricks: Non Angiogenic Effects of the VEGF/VEGFR Pathway in Cancer.
Ntellas P, Mavroeidis L, Gkoura S, Gazouli I, et al · · 2020 · cited 53× · PMID 33121034 · DOI 10.3390/cancers12113145
Systemic Therapy for Hepatocellular Carcinoma: Current Updates and Outlook.
Fan Y, Xue H, Zheng H. · · 2022 · cited 48× · PMID 35388357 · DOI 10.2147/jhc.s358082
Immunotherapy in hepatocellular carcinoma: evaluation and management of adverse events associated with atezolizumab plus bevacizumab.
Hsu C, Rimassa L, Sun HC, Vogel A, et al · · 2021 · cited 34× · PMID 34377156 · DOI 10.1177/17588359211031141
Overcoming resistance to immune checkpoint inhibitors in hepatocellular carcinoma: Challenges and opportunities.
Xie Q, Zhang P, Wang Y, Mei W, et al · · 2022 · cited 26× · PMID 36119533 · DOI 10.3389/fonc.2022.958720
Combination of molecularly targeted therapies and immune checkpoint inhibitors in the new era of unresectable hepatocellular carcinoma treatment.
Liu ZL, Liu JH, Staiculescu D, Chen J. · · 2021 · cited 17× · PMID 34104226 · DOI 10.1177/17588359211018026

Verify or expand the search:

Other trials of HLX10

Trials testing the same drug.

NCT07507916 — Dynamic ctDNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma · Phase 2 · not yet recruiting
NCT07457528 — Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC · Phase 2 · recruiting
NCT07113275 — A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Ne · Phase 3 · not yet recruiting
NCT06349980 — A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or W · Phase 2 · recruiting
NCT06115642 — A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors · Phase 1 · recruiting

Other recruiting trials for Hepatocellular Carcinoma (HCC)

Currently open trials in the same condition.

NCT07070076 — A Two-Arm, Multicenter, Non-Randomized Controlled Study on the Efficacy of Yttrium-90 (Selective Internal Radiation Ther · NA · recruiting
NCT07476651 — Scout Dose of Resin Microspheres · NA · recruiting
NCT07419841 — A Phase 1 Study of the Safety and Tolerability of CTX-10726 · Phase 1 · recruiting
NCT07490262 — A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular · Phase 2, PHASE3 · recruiting
NCT07291076 — A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants Wit · Phase 1, PHASE2 · recruiting

Other Shanghai Henlius Biotech trials

Trials by the same sponsor.

NCT07518043 — A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors · Phase 1 · not yet recruiting
NCT07477587 — A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in · Phase 1 · not yet recruiting
NCT07533708 — A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours · Phase 1 · not yet recruiting
NCT07484893 — A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects · Phase 1 · not yet recruiting
NCT07495930 — Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo® · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04465734 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Henlius Biotech
Last refreshed: 5 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04465734.

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