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Recruiting Phase 2

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

NCT06360042 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2024-01-01
Last updated
2024-04-22

Condition(s) studied

Unresectable Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

Adebrelimab plus ApatinibAll Adebrelimab trials (151) →All Apatinib trials (69) →Adebrelimab plus BevacizumabAll Adebrelimab trials (151) →All Bevacizumab trials (435) →Camrelizumab plus ApatinibAll Camrelizumab trials (108) →All Apatinib trials (69) →

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

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

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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: * 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

Primary outcome measure(s)

  • 12-month overall survival rate — Up to approximately 3 years

Trial sites (1)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06360042 on ClinicalTrials.gov ↗ ← All trials in China