Clinical trial · Interventional
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC)
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial
NCT03851887CI-TRIAL-00037228unknownPhase 2ClinicalTrials.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)
To evaluate the efiicacy of TAI combine SBRT in unresectable HCC
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 |
|---|---|---|---|
| TAI combine SBRT | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- TAI combine SBRT
- interventionNames
- Combination Product: TAI combine SBRT
Primary outcomes (2)
- measure
- PFS
- timeFrame
- From date of randomization until the date of progression, assessed up to 36 months
- description
- progression-free survival
- measure
- ORR
- timeFrame
- From date of randomization until the date of death, assessed up to 36 months
- description
- objective response rate
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * older than 18 years old and younger than 75 years; * ECOG PS≤1; * proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; * not previous treated for tumor; * cannot accepted hepatectomy; * the lab test could meet: * neutrophil count≥2.0×109/L; * hemoglobin≥100g/L; * platelet count≥75×109/L; * serum albumin≥35g/L; * total bilirubin\<2-times upper limit of normal; * ALT\<3-times upper limit of normal; * AST\<3-times upper limit of normal; * serum creatine\<1.5-times upper limit of normal; * PT≤upper limit of normal plus 4 seconds; * INR≤2.2; * sign up consent. Exclusion Criteria: * cannot tolerate TAI or SBRT; * known history of other malignancy; * be allergic to related drugs; * underwent organ transplantation before; * be treated before (interferon included); * known history of HIV infection; * known history of drug or alcohol abuse; * have GI hemorrhage or cardiac/brain vascular events within 30 days; * pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.