SOURCE Trial: Sorafenib in Portal Vein Tumor Thrombus

source trial

Here’s the extracted information from the provided visual abstract:

SOURCE

Adjuvant Transarterial Chemoembolization With Sorafenib for Portal Vein Tumor Thrombus

Study Design:

  • A phase 3, multicenter, randomized clinical trial.

Objective:

  • To explore the efficacy and safety of Sorafenib plus transarterial chemoembolization (TACE) versus Sorafenib alone as postoperative adjuvant therapy for patients with hepatocellular carcinoma (HCC) with portal vein tumor thrombus.

Participants:

  • Total: 158 Patients
  • Inclusion Criteria:
    • Aged 18-75 years
    • Primary HCC without any treatments
    • Received curative hepatic resection
    • ECOG score 0-1
    • Child-Pugh grade A
    • Sufficient liver and kidney function
  • Exclusion Criteria:
    • Diffused lesions
    • Tumor thrombosis in superior mesenteric vein (SMV) or inferior vena cava (IVC)
    • Extra-hepatic metastasis
    • Contraindication of TACE

Intervention Groups:

  • TACE plus Sorafenib (n = 79)
  • Sorafenib alone (n = 79)

Primary Outcome:

  • Recurrence-free survival (months)
  • Results:
    • TACE plus Sorafenib: 16.8 months
    • Sorafenib alone: 12.6 months
    • Hazard Ratio (HR): 0.57 (95% Confidence Interval (CI): 0.39-0.83; P = 0.002)

Secondary Outcomes:

  • Overall survival (months)
  • Results:
    • TACE plus Sorafenib: 30.4 months
    • Sorafenib alone: 22.5 months
    • HR: 0.57 (95% CI: 0.39-0.91; P = 0.02)
  • Most common grade 3/4 adverse event: Hand-foot syndrome
  • Results:
    • TACE plus Sorafenib: 29.1%
    • Sorafenib alone: 30.4%

Conclusion:

  • The combination of sorafenib and transarterial chemoembolization as postoperative adjuvant therapy resulted in longer recurrence-free survival and overall survival than sorafenib alone, and was well tolerated.

Citation:

  • Peng Z et al. JAMA Surg 2024. doi:10.1001/jamasurg.2024.0506

This summary captures the key points from the visual abstract, including study design, objectives, participant details, intervention groups, outcomes, and the conclusion.

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