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Table 3 The ongoing clinical trials of hepatocellular carcinoma (HCC) in China

From: Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets

Agent

Targets

Conditions and Stage

Phase

Primary endpoint(s)

Biomarker

Companies

ID numbera

Studystart

Immunotherapy

 Pembrolizumab

PD-1

Advanced; Second-line

III

OS

/

Merck Sharp & Dohme Corp.

CTR20160696

2017

 Tislelizumab (BGB-A317)

PD-1

Unresectable; First-line

III

OS/Safety

/

BeiGene.

NCT03412773

2017

 Toripalimab (JS001)

PD-1

Complete resection; Adjuvant

II/III

RFS

/

TopAlliance

Biosciences Inc.

NCT03859128

2019

 Camrelizumab (SHR-1210)

PD-1

Advanced; Second-line

II

ORR/OS (6 M)

/

Jiangsu HengRui Medicine Co., Ltd.

NCT02989922

2016

 CAR-T cell

EpCAM

EpCAM positive

I/II

Toxicity

/

First Affiliated Hospital of Chengdu Medical College.

NCT03013712

2017

 Infusion of iNKT cells and CD8+T cells

Lysis tumor cells

Advanced

I/II

AEs/ORR

/

Shanghai Public Health Clinical Center.

NCT03093688

2017

 KN035

PD-L1

Advanced

I

DLTs/AEs/ORR

/

3D Medicines (Sichuan) Co., Ltd.; Alphamab Co., Ltd.

NCT03101488

2017

 GLS-010 injection

PD-1

Advanced

I

AEs/AA

PD-L1

Harbin Gloria Pharmaceutical Co., Ltd.

CTR20170692

2017

 iNKT cells

Lysis tumor cells

Relapsed, advanced

I

AEs

/

Beijing YouAn Hospital.

NCT03175679

2017

 ET1402L1-CAR-T cells

AFP

AFP+, advanced

I

DLT/Toxicity

AFP

Aeon Therapeutics (Shanghai) Co., Ltd.

NCT03349255

2017

 GPC3-T2-CAR-T cells

GPC3

GPC3+

I

DLT

/

Second Affiliated Hospital of Guangzhou Medical University.

NCT03198546

2017

Anti-angiogenesis

 Donafenib

VEGFR, PDGFR, RAF

Advanced; First-line

III

OS

/

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

NCT02645981

2016

 Lenvatinib (E7080)

VEGFR1–3, FGFR1–4, PDGFR α, RET, and KIT

Unresectable;

First-line

III

OS

/

Eisai Co., Ltd.

CTR20131648

2014

 Muparfostat (PI-88)

FGF1–2, VEGF

Resected; Adjuvant

III

DFS

/

Medigen Biotechnology Corp.

CTR20131019

2015

 Brivanib (ZL-2301)

VEGFR, FGFR

Advanced; Second-line

II

DCR (3 M)

/

Zai Lab Pharmaceutical (Shanghai) Co., Ltd.

CTR20170216

2017

 Lucitanib (AL3810)

FGFR1–2, VEGFR1–3

Advanced or metastatic

Ib

AE

/

Shanghai Institute of Materia Medica; Academia Sinica.

CTR20160271

2016

 Metatinib Trometamol tablets

MET/VEGFR2

Advanced or metastatic

Ib

AE

MET

Simcere Pharmaceutical Co., Ltd.

CTR20150743

2015

 Chiauranib

VEGFR, PDGFRa, KIT, Aurora B and CSF-1R

Advanced

I

PFR (16 W)

/

Chipscreen Biosciences, Ltd.

NCT03245190

2018

Cell cycle inhibitors and Anti-proliferation

 Erdafitinib (JNJ-42756493)

FGFR

Advanced; FGF19 amplification

I/II

RP2D/ORR

/

Janssen Research & Development, LLC.

NCT02421185

2015

 ATG-008 (CC-223)

mTORC1/2

HBV+, Advanced; Second-line

II

PK/AEs/ORR

TORC1/2 and others

Antengene Corporation.

NCT03591965

2018

Combination therapy

 PD-1 Antibody Plus Lenvatinib

PD-1 + VEGFR1–3, FGFR1–4, PDGFR α, RET, and KIT

Advanced

III

OS

/

Sun Yat-sen University.

NCT03744247

2019

 HLX10 plus HLX04

PD-1+ VEGF

Locally Advanced or Metastatic;

First-line

III

OS/PFS

/

Shanghai Henlius Biotech.

NCT04465734

2020

 Durvalumab plus Tremelimumab

PD-L1 + CTLA-4

Unresectable;

First-line

III

OS/AE

/

MedImmune LLC.

CTR20180607

2018

 SHR-1210 plus FOLFOX4

PD-1 + DNA Synthesis

Advanced; First-line

III

OS

/

Jiangsu HengRui Medicine Co., Ltd.

NCT03605706

2018

 SHR-1210 plus Apatinib

PD-1 + VEGFR-2

Advanced; First-line

III

OS/PFS

/

Shanghai HengRui Medicine Co., Ltd.

CTR20182528

2019

 Sintilimab plus IBI305

PD-1 + VEGF

Advanced; First-line

II/III

OS/ORR

/

Innovent Biologics (Suzhou) Co. Ltd.

NCT03794440

2019

 AK105 plus Anlotinib or AK105 plus Bevacizumab

PD-1 + VEGFR, PDGFR, FGFR, KIT or PD-1 + VEGFA

Unresectable; First-line

Ib/II

ORR

/

Akeso (Guangdong) Biopharma, Inc.

CTR20182026

2018

 PD-1 mAb plus PolyIC

PD-1 + TLR3

Unresectable

II

ORR

AFP

Second Affiliated Hospital, School of Medicine, Zhejiang University.

NCT03732547

2018

 PHY906 plus Sorafenib

Chinese herbal formulation+VEGFRs, KIT, PDGFRs, and RAF

Advanced

I

RP2D

/

City of Hope Medical Center.

NCT01666756

2013

Traditional Chinese medicine

 Xihuang Capsules

/

Resected

IV

recurrence rate

/

Shuqun Cheng, Eastern Hepatobiliary Surgery Hospital.

NCT02399033

2015

 Icaritin

ERa36

Advanced; HBV-Related

III

OS

PD-L1, hnRNPAB1, IL-6 and others

Beijing Shenogen Biomedical Co., Ltd.

NCT03236636

2017

 Icaritin

ERa36

PD-L1+, advanced

III

OS

PD-L1, hnRNPAB1, IL-6 and others

Beijing Shenogen Biomedical Co., Ltd.

NCT03236649

2017

 Ursolic acid nanoliposomes injection

IKKβ

Advanced;

I

ORR

/

Wuhan Liyuanheng Pharmaceutical Co., Ltd.

CTR20140395

2016

 Chlorogenic acid

cell cycle

Advanced;

I

DLT/MTD

/

Sichuan Jiuzhang Biotech Co., Ltd.

CTR20130586

2014

 Jiu-wei-zhen-xiao Granule

/

Advanced; Unresectable

I

PFS

/

Zhong Wang, China Academy of Chinese Medical Sciences.

NCT03851471

2019

Other mechanisms

 K-001 (Marine biological products)

anti-inflammation, anti-angiogenesis

Advanced

III

OS

AFP

Beijing Huashi Tianfu Biomedical Technology Co., Ltd.

CTR20132910

2014

 IFN-alpha

pro-apoptosis, anti-proliferation

Resected; low miR-26 expression

III

DFS

miR-26

Fudan University.

NCT01681446

2012

 Galunisertib (LY2157299)

TGF-β

Advanced; First-line

II

OS

/

Eli Lilly and Company.

CTR20150343

2015

 Boanmycin Hydrochloride for Injection

cytotoxic agent

/

II

ORR

/

DIKANG Pharmaceutical.

CTR20140308

2015

 PT-112

pro-apoptosis, immunogenic cell death inducer

Advanced

I/II

AEs/DLTs/DCR

/

SciClone Pharmaceuticals.

NCT03439761

2018

 Hemay102

cytotoxic agent

Advanced;

I

AE

/

Hainan Hailing Chemipharma Corporation Limited.

CTR20181497

2018

 ZSP1241

/

Advanced

I

MTD/DLT/AEs

/

Guangdong Zhongsheng Pharmaceutical Co., Ltd.

NCT03734926

2018

 CGX1321

WNT

Advanced

I

AEs

/

Curegenix Inc.

NCT03507998

2017

  1. Abbreviations: PD-1 programmed cell death-1, PD-L1 programmed cell death ligand 1, EpCAM epithelial cell adhesion molecule, AFP alpha fetoprotein, GPC3 glypican 3, VEGFR vascular endothelial growth factor receptor, VEGF vascular endothelial growth factor, PDGFR platelet derived growth factor receptor, FGFR fibroblast growth factor receptor, FGF fibroblast growth factor, PDGFR platelet derived growth factor receptor, CSF-1R colony stimulating factor 1 receptor, mTORC1/2 mechanistic target of rapamycin kinase complex 1 and 2, TLR3 toll like receptor 3, CTLA-4 cytotoxic T lymphocyte–associated antigen-4, IKKβ inhibitor of nuclear factor kappa B kinase subunit beta, ERa36 estrogen receptor-alpha 36, TGF-β transforming growth factor beta, OS overall survival, RFS recurrence free survival, ORR objective response rate, DLT dose limited toxicity, AEs adverse events, DFS disease free survival, DCR disease control rate, PFR progression free rate, RP2D recommended phase II dose, PK pharmacokinetic, MTD maximum tolerated dose, PFS progress free survival
  2. aID number: IDs starting with NCT are from clinicaltrials.gov, while IDs starting with CTR are from chinadrugtrials.org.cn/index.html