✓ Translated by DotMD AI Clinical Council Source: Cardiovascular and interventional radiology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #35119481 ↗

Phase III Randomized Trial: Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment

Original Paper Title: “Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • The planned sample size, 950 patients, was calculated to permit accumulation of sufficient overall survival events in 5 years to achieve 90% power for the overall survival primary endpoint.
  • Study Design & Sample: Phase III Randomized Trial published in Cardiovascular and interventional radiology (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Cardiovascular and interventional radiology (2022), this phase iii randomized trial evaluating human clinical outcomes investigated: Transarterial chemoembolization (TACE) is the standard of care for patients with intermediate-stage hepatocellular carcinoma (HCC). Key clinical takeaway: The planned sample size, 950 patients, was calculated to permit accumulation of sufficient overall survival events in 5 years to achieve 90% power for the overall survival primary endpoint.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Cardiovascular and interventional radiology, 2022-04-15; Phase III Randomized Trial; Rigor 88/100): The planned sample size, 950 patients, was calculated to permit accumulation of sufficient overall survival events in 5 years to achieve 90% power for the overall survival primary endpoint.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: lenvatinib → Condition: malignant-neoplasm-of-unspecified-kidney-except-renal-pelvis → Condition: malignant-neoplasm-of-trigone-of-bladder →
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