Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06360042

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Jun Zhou

CONTACT

[email protected]

13366152815

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Adebrelimab plus Apatinib

Drug

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

Adebrelimab plus Bevacizumab

Drug

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

Camrelizumab plus Apatinib

Drug

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

Primary outcomes

  1. 12-month overall survival rate

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. ORR

    Time frame: Up to approximately 3 years

    Assessed by the investigator per RECIST v1.1 criteria

  2. DCR

    Time frame: Up to approximately 3 years

    Assessed by the investigator per RECIST v1.1 criteria

  3. DoR

    Time frame: Up to approximately 3 years

    Assessed by the investigator per RECIST v1.1 criteria

  4. TTR

    Time frame: Up to approximately 3 years

    Assessed by the investigator per RECIST v1.1 criteria

  5. TTP

    Time frame: Up to approximately 3 years

    Assessed by the investigator per RECIST v1.1 criteria

  6. PFS

    Time frame: Up to approximately 3 years

    Assessed by the investigator per RECIST v1.1 criteria

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Zhou

CONTACT

[email protected]

13366152815

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Therapy for Unresectable Hepatocellular Carcinoma: a Multicenter, Randomized, Open-label Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 11, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.