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RecruitingNCT06360042Updated Apr 22, 2024

Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC

A Phase 2 interventional study of Adebrelimab plus Apatinib and Adebrelimab plus Bevacizumab in Unresectable Hepatocellular Carcinoma, sponsored by Peking University Cancer Hospital & Institute. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Unresectable Hepatocellular Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 111 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
111 participants (estimated)

Study arms

  • Experimental
    1

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

    Drug: Adebrelimab plus Apatinib

  • Experimental
    2

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

    Drug: Adebrelimab plus Bevacizumab

  • Experimental
    3

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

    Drug: Camrelizumab plus Apatinib

Interventions

  • DrugAdebrelimab plus Apatinib

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

  • DrugAdebrelimab plus Bevacizumab

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

  • DrugCamrelizumab plus Apatinib

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

06

What researchers measure

Primary outcomes

  1. 12-month overall survival rate

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. ORR

    Assessed by the investigator per RECIST v1.1 criteria

    Time frame: Up to approximately 3 years

  2. DCR

    Assessed by the investigator per RECIST v1.1 criteria

    Time frame: Up to approximately 3 years

  3. DoR

    Assessed by the investigator per RECIST v1.1 criteria

    Time frame: Up to approximately 3 years

  4. TTR

    Assessed by the investigator per RECIST v1.1 criteria

    Time frame: Up to approximately 3 years

  5. TTP

    Assessed by the investigator per RECIST v1.1 criteria

    Time frame: Up to approximately 3 years

  6. PFS

    Assessed by the investigator per RECIST v1.1 criteria

    Time frame: Up to approximately 3 years

  7. OS

    Time frame: Up to approximately 3 years

  8. safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0.

    Time frame: Up to approximately 3 years

07

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06360042
Lead sponsor
Peking University Cancer Hospital & Institute
Responsible party
Sponsor
First posted
Apr 11, 2024
Start date
Jan 1, 2024
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Apr 22, 2024

Study contacts

Jun Zhou
Contact
Joelbmu@126.com
13366152815
Jun Zhou
principal investigator · Peking University Cancer Hospital & Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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