Clinical trial · Interventional
Study of Postoperative 3D-CRT/IMRT in Hepatocellular Carcinoma
Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study
NCT01456156CI-TRIAL-00028497completedN/AClinicalTrials.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)
Hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some patients can not receive radical resection. Such patients have high risk of recurrence. Tumor resection and postoperative radiation is an option for such patients to achieve radical treatment and radiation may reduce local recurrence.
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 Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| postoperative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- hepatectomy plus radiotherapy
- interventionNames
- Radiation: postoperative radiotherapy
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 3 year
- description
- the rate of overall survival for 3 year
Secondary outcomes (3)
- measure
- local recurrence free survival
- timeFrame
- 3 years
- description
- the rate of local recurrence free survival for 3 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * written informed consent provided * 18\~75 years old * patients with histopathological proved hepatocellular carcinoma received hepatectomy and had at least one risk factor of recurrence * without any lymph node or distant metastasis (any T N0M0) * liver function: Child-Pugh A or B * Performance status: Karnofsky (KPS)≥70 or world health organization(WHO) score 0,1 * life expectation\>6 months * no dysfunction of major organs * no prior radiotherapy * negative for human immunodeficiency virus syndrome (HIV) * Considerable to computed tomography(CT) simulation and 3D-CRT or IMRT Exclusion Criteria: * malignant tumors of other sits * combining severe diseases, such as acute myocardial infarction(AMI), arrhythmias, infection * surgery performed in other hospitals without details * pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG)
References
Publications (1)
- DERIVEDChen B, Wu JX, Cheng SH, Wang LM, Rong WQ, Wu F, Wang SL, Jin J, Liu YP, Song YW, Ren H, Fang H, Tang Y, Li N, Li YX, Wang WH. Phase 2 Study of Adjuvant Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC. Hepatology. 2021 Nov;74(5):2595-2604. doi: 10.1002/hep.31993. Epub 2021 Sep 16. PMID 34097307