NCT04444167

Brief Summary

An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

July 7, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

3.4 years

First QC Date

June 21, 2020

Last Update Submit

April 23, 2024

Conditions

Hepatocellular Carcinoma

Keywords

VEGFAnti-PD-1Tyrosine Kinase Inhibitor (TKI)Anti-CTLA-4

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.

    Up to 2 years

Secondary Outcomes (6)

  • Disease control rate (DCR)

    Up to 2 years

  • Duration of response (DoR)

    Up to 2 years

  • Progression-free survival (PFS)

    Up to 2 years

  • Number of participants with adverse events (AEs)

    the time of informed consent signed through 90 days after the last dose of AK104 and

  • Observed concentrations of AK104

    From first dose of AK104 through 90 days after last dose of AK104

  • +1 more secondary outcomes

Study Arms (1)

AK104 and Lenvatinib

EXPERIMENTAL

AK104 6 mg/kg IV every 2 weeks (Q2W) Lenvatinib 12mg weight≥60kg or 8mg weight\<60kg,PO QD

Biological: AK104Drug: Lenvatinib

Interventions

AK104BIOLOGICAL

Subjects will receive AK104 and lenvatinib until disease progression or for a maximum of 24 months

AK104 and Lenvatinib
LenvatinibDRUG

Subjects will receive AK104 and lenvatinib until disease progression for a maximum of 24 months

AK104 and Lenvatinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent form voluntarily.
  • Histologically or cytologically documented hepatocellular carcinoma.
  • BCLC stage C, and non-resectable BCLC stage B .
  • At least one measurable lesion according to RECIST criteria.
  • ECOG of 0 or 1.
  • Adequate organ function.
  • Estimated life expectancy of ≥3 months.
  • For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent.

You may not qualify if:

  • Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
  • History of hepatic encephalopathy or liver transplantation.
  • Clinical significance of hydrothorax, ascites or pericardial effusion.
  • Central nervous system metastases and/or carcinomatous meningitis.
  • Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
  • Occurred arteriovenous thromboembolic events within 6 months before the first administration.
  • Tumor volume \> 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus.
  • Inadequately controlled arterial hypertension.
  • Attack of symptomatic congestive heart failure (LVEF\<50%); History of congenital long QT syndrome.
  • Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
  • Severe infections.
  • Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
  • Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
  • Unable to receive an enhanced CT or MRI scan of the liver.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • Qiao Q, Han C, Ye S, Li J, Shao G, Bai Y, Xu A, Sun M, Wang W, Wu J, Huang M, Song L, Huang L, Liu T, Liu W, Wang ZM, Li B, Xia M, Bai L. The efficacy and safety of cadonilimab combined with lenvatinib for first-line treatment of advanced hepatocellular carcinoma (COMPASSION-08): a phase Ib/II single-arm clinical trial. Front Immunol. 2023 Oct 24;14:1238667. doi: 10.3389/fimmu.2023.1238667. eCollection 2023.

    PMID: 37942328DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Li Bai, MD

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

  • Shunchang Jiao, MD

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 23, 2020

Study Start

July 7, 2020

Primary Completion

November 20, 2023

Study Completion

November 20, 2023

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations

CN(1)