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Recruiting NCT06360042

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

Phase II Interventional Unresectable Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adebrelimab plus Apatinib, Adebrelimab plus Bevacizumab, Camrelizumab plus Apatinib.
Who it may be relevant to
Registry conditions: Unresectable Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug Adebrelimab plus Apatinib
    Adebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily
  • Drug Adebrelimab plus Bevacizumab
    Adebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks
  • Drug Camrelizumab plus Apatinib
    camrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily

Primary outcome measures

  • 12-month overall survival rate [Time frame: Up to approximately 3 years]
Secondary outcome measures (8)
  • ORR [Time frame: Up to approximately 3 years]
  • DCR [Time frame: Up to approximately 3 years]
  • DoR [Time frame: Up to approximately 3 years]
  • TTR [Time frame: Up to approximately 3 years]
  • TTP [Time frame: Up to approximately 3 years]
  • PFS [Time frame: Up to approximately 3 years]
  • OS [Time frame: Up to approximately 3 years]
  • safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0. [Time frame: Up to approximately 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT06360042 · MA-HCC-II-021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗