NCT06360042

Brief Summary

This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
23mo left

Started Jan 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress55%
Jan 2024Mar 2028

Study Start

First participant enrolled

January 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

April 22, 2024

Status Verified

November 1, 2023

Enrollment Period

3.2 years

First QC Date

February 27, 2024

Last Update Submit

April 19, 2024

Conditions

Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 12-month overall survival rate

    Up to approximately 3 years

Secondary Outcomes (8)

  • ORR

    Up to approximately 3 years

  • DCR

    Up to approximately 3 years

  • DoR

    Up to approximately 3 years

  • TTR

    Up to approximately 3 years

  • TTP

    Up to approximately 3 years

  • +3 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

Adebrelimab（1200mg iv q3w） plus Apatinib(250mg po qd)

Drug: Adebrelimab plus Apatinib

2

EXPERIMENTAL

Adebrelimab（1200mg iv q3w）plus Bevacizumab(15mg/kg iv q3w)

Drug: Adebrelimab plus Bevacizumab

3

EXPERIMENTAL

Camrelizumab (200mg iv q2w) plus Apatinib(250mg po qd)

Drug: Camrelizumab plus Apatinib

Interventions

Adebrelimab plus ApatinibDRUG

Adebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily

1
Adebrelimab plus BevacizumabDRUG

Adebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks

2
Camrelizumab plus ApatinibDRUG

camrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily

3

Eligibility Criteria

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

You may qualify if:

  • Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
  • No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed.
  • BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
  • At least one measurable lesion per RECIST v1.1
  • ECOG Performance Status of 0 or 1
  • Child-Pugh class of A5 to B7
  • Adequate organ function

You may not qualify if:

  • Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
  • Moderate-to-severe ascites with clinical symptoms
  • History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
  • Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
  • Known genetic or acquired hemorrhage or thrombotic tendency
  • Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
  • Hypertension that can not be well controlled through antihypertensive drugs Factors to affect oral administration
  • History of hepatic encephalopathy
  • Previous or current presence of metastasis to central nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

apatinibBevacizumabcamrelizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jun Zhou

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhou

CONTACT

13366152815Joelbmu@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2024

First Posted

April 11, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

April 22, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)