Clinical trial · Interventional
Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI
Adjuvant Stereotactic Body Radiation for Hepatocellular Carcinoma With Microvascular Invasion and Narrow Resection Margin
NCT04891874CI-TRIAL-00053828completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SBRT group
- description
- Participants in SBRT group will receive SBRT as adjuvant radiotherapy for hepatocellular carcinoma with microvascular invasion and narrow resection margin.
- interventionNames
- Radiation: Stereotactic radiotherapy
- type
- NO_INTERVENTION
- label
- Surgery alone group
- description
- Participants in surgery alone group will not receive any adjuvant therapy after surgery for hepatocellular carcinoma.
Primary outcomes (1)
- measure
- Participants Without Recurrence (Disease-free).
- timeFrame
- DFS rate at 5-years after randomization.
- description
- Participants will be monitored for recurrence(disease) since enrollment. DFS was defined as time interval from randomization to the first recurrence. The unit of measure was month.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. solitary nodule; 2. 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); 3. macro-vascular negative; 4. no previous treatment before surgery; 5. no previous hepatic surgery; 6. Child-Pugh score A for hepatic function. Exclusion Criteria: 1. spontaneous rupture; 2. pathologically proved positive resection margin; 3. severe cirrhosis with hypersplenism or esophageal and gastric varices; 4. 4-weeks postoperative examination revealed α-fetal protein(AFP) still positive or new lesion in remnant liver; 5. postoperative complications required a secondary operation or more than 3 weeks'recovery from surgery.
References
Publications (1)
- DERIVEDShi C, Li Y, Geng L, Shen W, Sui C, Dai B, Lu J, Pan M, Yang J. Adjuvant stereotactic body radiotherapy after marginal resection for hepatocellular carcinoma with microvascular invasion: A randomised controlled trial. Eur J Cancer. 2022 May;166:176-184. doi: 10.1016/j.ejca.2022.02.012. Epub 2022 Mar 15. PMID 35303509