Clinical trial · Interventional
SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT
SBRT Sequential TACE Combined With Sorafenib Versus Sorafenib Alone in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus：A Single-center Randomized Controlled Study
NCT04387695CI-TRIAL-00063988unknownPhase 3ClinicalTrials.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 and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Portal Vein Thrombosis | — | UNRESOLVED | — |
| Unresectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT+TACE+Sorafenib | Radiation | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SBRT + TACE + Sorafenib
- description
- SBRT sequential TACE combined with Sorafenib
- interventionNames
- Radiation: SBRT+TACE+Sorafenib
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- description
- Sorafenib 800 mg/day orally
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Progression-free survival (PFS) rate
- timeFrame
- at 12 weeks after randomization
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Child-Pugh score ≤ 7 * Performance status: ECOG score ≤ 2 * HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017 * the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline * No previous therapy for HCC * at least one measurable target lesion according to RECIST 1.1 * Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3 * Serum total bilirubin ≤ 2 x ULN * Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN * Creatinine ≤ 1.5 x ULN * No plan for pregnancy or breast feeding. Active contraception. * Willing to give informed consent Exclusion Criteria: * Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib * Complete obstruction of hepatic outflow * Uncontrolled ascites of hepatic encephalopathy * Prior liver transplantation * Positive for human immunodeficiency virus (HIV) * Active gastric or duodenal ulcer * Other uncontrolled comorbidities or malignancy * Inability to give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.