Clinical trial · Interventional
Efficacy of Localized Concurrent Chemo-radiation Therapy and Sorafenib Sequential Therapy in Advanced Hepatocellular Carcinoma
Efficacy of Localized Concurrent Chemo-radiation Therapy and Sorafenib Sequential Therapy in Advanced Hepatocellular Carcinoma: a Prospective Phase 2 Trial
NCT02425605CI-TRIAL-00037257completedPhase 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)
This is a single-center, single-arm, open-label, prospective phase 2 trial to assess the efficacy of localized concurrent chemoradiation therapy (CCRT) and sorafenib sequential therapy in subjects with advanced HCC. Approximately 47 subjects will be enrolled and will receive CCRT and sorafenib sequentially until all-cause mortality.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CCRT | Radiation | — | UNRESOLVED |
| sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CCRT-sorafenib group
- interventionNames
- Radiation: CCRT
- Drug: sorafenib
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 36 months after the enrollment
Secondary outcomes (4)
- measure
- PFSL defined as dynamic CT scan
- timeFrame
- 36 months after the enrollment
- description
- Progression-free survival in the liver(PFSL)
- measure
- PFSO defined as definitive imaging technique
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must have confirmed diagnosis of unresectable hepatocellular carcinoma (HCC) categorized to stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system with any of following criteria: 1) Lesion limited to a single lobe that is within the radiotherapy field, 2) Lesion not limited to a single lobe, but the lesion that is not within the radiotherapy field can be controlled by transarterial chemoembolization or radiofrequency ablation, 3) Presence of metastatic lesions that measure \< 1.0 cm in the long axis, 4) The lesion can be accurately measured in at least one dimension as ≥ 1.0 cm * Males or females aged at least 20 years and below 76 years * Eastern Cooperative Oncology Group performance status (ECOG-PS) 0 or 1 * Adequate liver function, defined as: 1) Child-Pugh score ≤ 7, 2) Bilirubin ≤ 3.0 mg/dL * Adequate bone marrow function, defined as: 1) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, 2) White blood cell count (WBC) ≥ 4.0 × 109/L, 3) Platelet count ≥ 60 × 109/L * Adequate renal function, defined as serum creatinine \< 2.0 mg/dL * Subjects with hepatitis B virus (HBV)-related HCC must have adequately controlled HBV replication status * Adequate blood coagulation factors, defined as international normalized ratio (INR) ≤ 2.3 * Provide written informed consent * Willing and able to comply with all aspects of the protocol Exclusion Criteria: * Significant liver function impairment, defined as bilirubin \> 3.0 mg/dL or uncontrolled ascites * Imaging findings for HCC corresponding to any of the following: 1) Diffuse HCC with \> 50% liver occupation, that is not adequate for external radiotherapy, 2) Presence of metastatic lesions that measure ≥ 1.0 cm in the long axis * Uncontrolled significant active infection * Presence of active malignancy (except for HCC) * Females who are lactating or pregnant; females of childbearing potential who have not received pregnancy test or shown positive on pregnancy test * Any medical or other condition that in the opinion of the investigator would preclude the subject's participation in a clinical study * Major surgery within 4 weeks prior to enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.