Skip to main content

Table 4 Key ongoing advanced hepatocellular carcinoma immunotherapy clinical trials

From: Biomarkers and prognostic factors of PD-1/PD-L1 inhibitor-based therapy in patients with advanced hepatocellular carcinoma

NCT number

Phase

(Estimated Number); Line

Target population

(Region)

Regimen

Primary endpoint

Status

(Estimated Completion Date)

Categories

Therapeutic reagent types

NCT04194775

III (N = 534); 1st

Histologically, cytologically, or clinically confirmed; BCLC stage B/C (Global)

CS1003(PD-1 inhibitor) + Lenvatinib vs. Placebo + Lenvatinib

OS

Active, not recruiting

(June 30, 2025)

Anti-PD-1 + TKI

IgG4 mAb + TKI

NCT04523493

III (N = 530); 1st

Histological or cytologically confirmed; BCLC stage B/C (Global)

Toripalimab (PD-1 inhibitor) + Lenvatinib vs. Placebo + Lenvatinib

OS

Active, not recruiting

(September 1, 2026)

Anti-PD-1 + TKI

IgG4 mAb + TKI

CTR20200192

III (N = 528); 1st

Histological or cytologically confirmed; BCLC stage B/C (Global)

JS001 (PD-1 inhibitor) + Bevacizumab vs. Sorafenib

OS; PFS

Recruiting

(NA)

Anti-PD-1 + anti-VEGF

IgG4 mAb + IgG1 mAb

NCT04560894

II/III (N = 621); 1st

Unresectable HCC; BCLC stage B/C (China)

SCT-I10A (PD-1 inhibitor) + SCT510 vs. Sorafenib

OS; PFS

Recruiting

(September 2024)

Anti-PD-1 + anti-VEGF

IgG4 mAb + mAb

NCT05603039

Ib/II (N = 80); 1st

Histologically or clinically confirmed (China)

QL1604 (PD-1 inhibitor) + Bevacizumab

ORR

Recruiting

(December 30, 2023)

Anti-PD-1 + anti-VEGF

IgG4 mAb + IgG1 mAb

NCT04444167

Ib/II (N = 30); 1st

Histological or cytologically confirmed; BCLC stage B/C (China)

AK104 (PD-1/CTLA-4 bispecific antibody) + Lenvatinib

ORR

Recruiting

(October 30, 2023)

PD-1/CTLA-4 bispecific antibody + TKI

IgG1 tetrameric BsAb + TKI

NCT05603039

Ib/II (N = 80); 1st

Histologically or clinically confirmed (China)

QL1706 (PD-1/CTLA-4 two engineered monoclonal antibodies) + Bevacizumab

ORR

Recruiting

(December 30, 2023)

PD-1/CTLA-4 bispecific antibody + anti-VEGF

Single bifunctional MabPair product + IgG1 mAb

NCT04542837

II (N = 55); 1st

Histological or cytologically confirmed; BCLC stage B/C (China)

KN046 (PD-L1 /CTLA-4 bispecific antibody) + Lenvatinib

ORR

Recruiting

(May 21, 2023)

PD-L1/CTLA-4 bispecific antibody + TKI

IgG1 Fc BsAb + TKI

NCT04948697

II (N = 90); 1st

Histologically confirmed; BCLC stage B/C (China)

Ociperlimab (anti-TIGIT) + Tislelizumab + BAT1706(anti-VEGF) vs. Tislelizumab + BAT1706

ORR

Active, not recruiting

(August 2023)

Anti-TIGIT + anti-PD-1 + anti-VEGF

IgG1 mAb + IgG4 mAb + mAb

NCT04524871

(Morpheus-Liver)

Ib/II (N = 400); 1st

Histologically, cytologically, or clinically confirmed; advanced HCC (Global)

Atezolizumab (PD-L1 inhibitor) + Bevacizumab + Tiragolumab (anti-TIGIT antibody)

Atezolizumab (PD-L1 inhibitor) + Bevacizumab + Tocilizumab

Atezolizumab (PD-L1 inhibitor) + Bevacizumab + TPST-1120 (PPARα antagonist)

Bevacizumab + RO7247669 (PD1-LAG3 Bispecific Antibody)

Atezolizumab (PD-L1 inhibitor) + Bevacizumab + ADG126 (anti-CTLA-4 SAFEbody)

Atezolizumab + Bevacizumab

ORR

Recruiting

(December 27, 2025)

Umbrella study

Atezolizumab: IgG1 mAb; Bevacizumab: IgG1 mAb;

Tiragolumab: IgG1/kappa mAb; TPST-1120: oral PPARα antagonist;

RO7247669: BsAb;

ADG126: masked anti-CTLA-4 SAFEbody

NCT05904886

(IMbrave152)

III (N = 650); 1st

Histologically or cytologically confirmed; locally advanced or metastatic and/or unresectable HCC (United States)

Tiragolumab (anti-TIGIT antibody) + Atezolizumab (PD-L1 inhibitor) + Bevacizumab vs. Atezolizumab + Bevacizumab + Placebo

OS, PFS

Not yet recruiting

(September 1, 2026)

Anti-TIGIT + anti-PD-L1 + anti-VEGF

IgG1 kappa mAb + IgG1 mAb + IgG1 mAb

NCT04246177

(LEAP-012)

III (N = 450); 1st

Radiology, histology, or cytology confirmed; intermediate stage (Global)

Pembrolizumab (PD-1 inhibitor) + Lenvatinib + TACE vs. Placebo + TACE

OS, PFS

Active, not recruiting

(December 31, 2029)

Anti-PD-1 + TKI + TACE

TKI + IgG4 kappa mAb + locoregional therapy

NCT04777851

(REPLACE)

III (N = 496); 1st

Radiology, histology, or cytology confirmed; intermediate stage (Global)

Nivolumab (PD-1 inhibitor) + Regorafenib vs. TACE

PFS

Not yet recruiting

(April 2027)

Anti-PD-1 + TKI vs. TACE

IgG4 mAb + TKI

NCT04803994

(ABC-HCC)

III (N = 434); 1st

Histological or radiology confirmed; intermediate stage (Global)

Atezolizumab (PD-L1 inhibitor) + Bevacizumab vs. TACE

Time to failure of treatment strategy

Recruiting

(April 1, 2025)

Anti-PD-L1 + anti-VEGF vs. TACE

IgG1 mAb + IgG1 mAb + locoregional therapy

Atezolizumab (PD-L1 inhibitor) + Bevacizumab + TACE

NCT04712643

(ML-42,612)

III (N = 342); 1st

Histology/ cytology confirmed (Global)

Atezolizumab (PD-L1 inhibitor) + Bevacizumab + TACE vs. TACE

PFS; OS

Recruiting

(February 28, 2029)

Anti-PD-L1 + anti-VEGF + TACE

IgG1 mAb + IgG1 mAb + locoregional therapy

NCT03778957

(EMERALD-1)

III (N = 724); 1st

Intermediate stage; without extrahepatic disease or main portal vein thrombosis (Vp3/Vp4) (Global)

Arm A: TACE + Durvalumab (PD-L1 inhibitor)

PFS for Arm B vs. Arm C

Active, not recruiting

(August 19, 2024)

Anti-PD-L1 + anti-VEGF + TACE

IgG1 kappa mAb + IgG1 mAb + locoregional therapy

Arm B: TACE + Durvalumab (PD-L1 inhibitor) + Bevacizumab

Arm C: TACE + Placebo

NCT04224636

(DEMAND)

II (N = 106); 1st

Histologically confirmed (Germany)

Up-front Atezolizumab (PD-L1 inhibitor) + Bevacizumab, then TACE

24-months survival rate

Recruiting

(March 1, 2025)

Anti-PD-L1 + anti-VEGF + TACE

IgG1 mAb + IgG1 mAb + locoregional therapy

NCT05301842

(EMERALD-3)

III (N = 525); 1st

Locoregional HCC (Global)

Arm A: TACE + Durvalumab (PD-L1 inhibitor) + Tremelimumab + Lenvatinib

PFS for Arm A vs. Arm C

Recruiting

(February 26, 2027)

Anti-PD-L1 + anti-CTLA-4 + TKI + TACE

IgG1 kappa mAb + IgG2 mAb + TKI + locoregional therapy

Arm B: TACE + Durvalumab (PD-L1 inhibitor) + Tremelimumab

Arm C: TACE

NCT05063565

(ROWAN)

II (N = 100); 1st

Radiology or cytology confirmed; portal vein thrombosis (Vp0, Vp1, or Vp2); intermediate stage (United States, Spain)

SIRT followed STRIDE

ORR

Recruiting

(June 2027)

Anti-PD-L1 + anti-CTLA-4 + SIRT

IgG1 kappa mAb + IgG2 mAb + radiation therapy

NCT04770896 (IMbrave251)

III (N = 554); 2nd

Histologically, cytologically, or clinically confirmed; advanced HCC (Global)

Atezolizumab (PD-L1 inhibitor) + Lenvatinib/ Sorafenib vs. Lenvatinib/ Sorafenib alone

OS

Recruiting

(September 23, 2024)

Anti-PD-L1 + TKI

IgG1 mAb + TKI

NCT04696055

II (N = 95); 2nd

Histological or cytological confirmed; BCLC stage B/ C (Global)

Pembrolizumab (PD-1 inhibitor) + Regorafenib

ORR

Active, not recruiting

(May 15, 2024)

Anti-PD-1 + TKI

IgG4 kappa mAb + TKI

NCT05873244

II(N = 44); 2nd and more

Prior treatment with systemic treatment consisting of immune checkpoint inhibitors; Child-Pugh class A; ECOG PS of 0 or 1.

Geptanolimab (PD-1 inhibitor) + Zabadinostat (class 1 HDAC inhibitor) vs. Lenvatinib/ Sorafenib alone

PFS

Recruiting

(December 30, 2027)

Anti-PD-1 +

HDAC inhibitor

IgG4 mAb + HDAC inhibitor

  1. Abbreviations: BsAb, bispecific antibody; CTLA-4, Cytotoxic T lymphocyte-associated antigen 4; HCC, hepatocellular carcinoma; HDAC, histone deacetylase; IgG, Immunoglobulin G; mAb, monoclonal antibody; ORR, objective response rate; OS, overall survival; PD-1, programmed death-1; PD-L1, programmed death ligand 1; PFS, progression-free survival; PPARα, peroxisome proliferator-activated receptor alpha; SIRT, selective internal radiation therapy; STRIDE, Single Tremelimumab Regular Interval Durvalumab; TACE, transarterial chemoembolization; TIGIT, T cell immunoglobulin and ITIM domain; TKI, tyrosine kinase inhibitor; trAE, treatment-related adverse event; VEGF, anti-vascular endothelial growth factor
Back to article page

Biomarker Research

ISSN: 2050-7771

Contact us