N/A
N=76
Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04891874 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Participants Without Recurrence (Disease-free). — 16; 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stereotactic radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Hepatobiliary Surgery Hospital
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Without Recurrence (Disease-free). |
16; 28 | — |
| SECONDARY Overall Survival (OS) Rate. |
29; 20 | — |
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.
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.
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.