Clinical trial · Interventional
Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
- 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)
This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(\<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.
Conditions
Conditions (3)
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 |
| Narrow Margin | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant SIB radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adjuvant SIB radiotherapy
- description
- Adjuvant integrated boost radiotherapy following narrow-margin hepatectomy in patients with HCC.
- interventionNames
- Radiation: Adjuvant SIB radiotherapy
Primary outcomes (1)
- measure
- The 3-year Overall Survival
- timeFrame
- up to 36 months
- description
- The 3-year overall survival was calculated from the date of surgical resection to the date of death from any cause.
Secondary outcomes (4)
- measure
- Disease-free Survival (DFS)
- timeFrame
- up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (\< 1 cm) * Age \> 18 years * Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1 * Child-Push Score: A5-A6 * Estimated life expectancy \> 3 months * No distant metastasis (M0) * Blood routine examination: Hb≥80g/L, ANC≥1.0x10\^9/L, PLT≥50x10\^9/L * Hepatic function: alanine transaminase(ALT) and aspartate transaminase(AST) ≤1.5 times ULN; or ALT ≤ULN and AST ≤6 times ULN exclude possibility of heart disease * Renal function: creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN * Voluntary to participate and sign informed consent Exclusion Criteria: * History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix * Had prior abdominal irradiation * Had prior liver transplantation * Had serious myocardial disease or renal failure * Had moderate or severe ascites with obvious symptoms * Duration from surgery ≥ 3 months
References
Publications (0)
Data not yet available