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N/A Completed N=76 Randomized Single-blind Treatment

Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI

Source: ClinicalTrials.gov NCT04891874 ↗
Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Participants Without Recurrence (Disease-free). — 16; 28 Participants

Summary

Positive micro vascular invasion in early stage hepatocellular carcinoma(HCC) leads to early recurrence after surgery. Adjuvant external radiotherapy will be applied in those patients to see if disease free survival and overall survival could be approved.

Outcome Measures

OutcomeResultp-value
PRIMARY
Participants Without Recurrence (Disease-free).
16; 28
SECONDARY
Overall Survival (OS) Rate.
29; 20

Eligibility Criteria

Inclusion Criteria

  • solitary nodule;
  • tumor adjacent to the main trunk of hepatic vein, cava vena, or to the major branch of portal vein (including the lobar branch at least);
  • macro-vascular negative;
  • no previous treatment before surgery;
  • no previous hepatic surgery;
  • Child-Pugh score A for hepatic function.

Exclusion Criteria

  • spontaneous rupture;
  • pathologically proved positive resection margin;
  • severe cirrhosis with hypersplenism or esophageal and gastric varices;
  • 4-weeks postoperative examination revealed α-fetal protein(AFP) still positive or new lesion in remnant liver;
  • postoperative complications required a secondary operation or more than 3 weeks'recovery from surgery.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04891874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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