Clinical trial · Interventional
Phase II Study of Concurrent Sorafenib and Intensity-modulated Radiotherapy (IMRT) for Advanced Hepatocellular Carcinoma
- 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 phase II clinical trial to investigate the efficacy and toxicity of concurrent sorafenib and intensity-modulated radiotherapy (IMRT) for advanced hepatocellular carcinoma with portal vein or hepatic vein tumor thrombosis or lymph node involved. Eligibility patients will receive IMRT to hepatic primary tumor, vein tumor thrombosis, and metastasis lymph node with concurrently sorafenib with a dose of 400mg twice daily. Prescription of IMRT will be a conventional fraction dose of 2Gy to a total dose of 40 to 60Gy. Sorafenib will be maintained with a dose of 400mg twice daily after IMRT until disease progression, or unacceptable adverse events. Six months of sorafenib maintenance is recommended.
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, Radiotherapy, Sorafenib | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| concurrent sorafenib and IMRT, followed sorafenib maintenance | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib and IMRT
- description
- Concurrent sorafenib and IMRT, followed sorafenib maintenance for advanced hepatocellular carcinoma with portal vein or hepatic vein tumor thrombosis or lymph node involved
- interventionNames
- Radiation: concurrent sorafenib and IMRT, followed sorafenib maintenance
Primary outcomes (1)
- measure
- MST
- timeFrame
- 24 months
- description
- Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause
Secondary outcomes (3)
- measure
- ORR
- timeFrame
- Assessment in 1 to 3 months after IMRT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical or histologic diagnosis of Hepatocellular carcinoma (HCC) 2. Aged between 18 and 80 years 3. ECOG 0-1 4. Liver-GTV\>700ml 5. BCLC stage C, HCC with portal vein or hepatic vein tumor thrombosis or lymph node involved (LN involved can be included one treatment planning) 6. Estimated life expectancy \> 3 months 7. Child-Pugh Score: A5-B8 8. 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 9. Renal function: creatinine (CRE) and blood urea nitrogen (BUN)≤ 1.5 times ULN 10. Blood routine examination: Hb≥80g/L, ANC≥1.0×109 /L, PLT≥40×109 /L 11. Voluntary to participate and sign informed consent Exclusion Criteria: 1. Had prior abdominal irradiation 2. Had prior liver transplantation 3. Had serious myocardial disease or renal failure 4. Pregnant, breast feeding, or unwilling to use adequate contraception 5. Known hypersensitivity to sorafenib
References
Publications (1)
- DERIVEDZhai Y, Wang L, Zhao H, Wu F, Xin L, Ye F, Sun W, Song Y, Niu L, Zeng H, Wang J, Tang Y, Song Y, Liu Y, Fang H, Lu N, Jing H, Qi S, Zhang W, Wang S, Li YX, Wu J, Chen B. Phase II study with sorafenib plus radiotherapy for advanced HCC with portal and/or hepatic vein tumor thrombosis. JHEP Rep. 2024 Nov 28;7(3):101287. doi: 10.1016/j.jhepr.2024.101287. eCollection 2025 Mar. PMID 39980754