Clinical trial · Interventional
Effectiveness and Safety of the Simultaneous Radiotherapy and Hyperthermia After Transarterial Chemoembolization in Hepatocellular Carcinoma Patients Combined With Portal Vein Tumor Thrombosis
Effectiveness and Safety of the Simultaneous Radiotherapy and Hyperthermia After Transarterial Chemoembolization in Hepatocellular Carcinoma Patients Combined With Portal Vein Tumor Thrombosis: Prospective Phase II Trial
- 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)
The presence of portal vein tumor thrombosis (PVTT)in patients with HCC is one of the most significant prognostic factors for poor prognosis, without treatment, their survival is less than 3 months. In the HCC patients who combined with PVTT, RT showed 50% of local control and about 10 months survival duration. Despite the standard treatment of the HCC combined with PVTT is sorafenib, but Korean Liver Cancer Study Group (KLCSG) recommend RT as an option in those patients. Investigators previously reported the retrospective study that the scheduled interval TACE followed by RT for HCC combined with PVTT and 60% of the patients showed objective response without significant elevation of complication. It is reported that hyperthermia considered as the most valuable radiosensitizer in cancer treatment, theoretically. Based on those studies, we start this prospective study to evaluate the objective response and adverse event in the combination treatment of RT and hyperthermia after Transarterial chemoembolization (TACE) in the unresectable HCC patients who combined with PVTT.
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 |
|---|---|---|---|
| Carcinoma. Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RT and hyperthermia after TACE | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RTHT
- description
- RT and hyperthermia after TACE in the unresectable HCC patients who combined with PVTT
- interventionNames
- Radiation: RT and hyperthermia after TACE
Primary outcomes (1)
- measure
- Hyperthermia effect and averse event in RT for HCC with PVTT
- timeFrame
- Radiologic response and adverse event will be evaluated at 3 month after treatment.
- description
- Modified response evaluation criteria in solid tumor(mRECIST) will be used. Objective response was defined as complete and partial response. The common terminology criteria for adverse events (CTCAE version 4.0) will be used to evaluate the adverse events.
Secondary outcomes (6)
- measure
- Hyperthermia effect on local progression free survival rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients must have a diagnosis of HCC by at least one criterion listed below (korean liver cancer study group (KLCSG) guideline 2009) 1.1 Pathologically (histologically or cytologically) proven diagnosis of HCC 1.2 Liver nodule in high risk group 1.2.1 If alpha fetoprotein (AFP) ≥200 ng/mL , ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI 1.2.2 If AFP\<200 ng/mL, ≥2 typical HCC enhancing pattern on dynamic contrast enhanced CT, MRI, and angiography 1.3 ≥ 2 cm nodule in liver cirrhosis (LC), ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI
2. Patients must have a diagnosis of PVTT 2.1 Early arterial enhancement and delayed washout on multiphasic CT or MRI
3. Eastern cooperative oncology group performance status 0 1 2
4. Age ≥ 20
5. Unsuitable for resection or transplant or RFA
6. Unsuitable for or refractory to TACE or drug eluting beads (DEB)
7. Agreement of study-specific informed consent
8. Assessment by radiation oncologist and medical oncologist or hepatologist within 28 days prior to study entry?
9. Child-Pugh score A-B within 7 days prior to study entry
10. Normal liver (Liver minus gross tumor volume) ≥ 700 cc
11. Blood work requirements
* Absolute neutrophil count (ANC) ≥ 1,500 /mm3, Platelet ≥ 70,000/mm3, Hgb ≥ 8 g/dl
* Liver function test (LFT): Total bilirubin\<3.0 mg/dL, International normalized ratio(INR) \< 1.7, Albumin ≥ 2.8g/dL, Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT)\< 6 X normal
* Serum creatinine \< 1.5 X normal, or creatinine clearance ≥ 60 mL/min
12. Male, consent contraception at least 6 months
13. Childbearing potential woman, consent contraception at least 6 months
14. Life expectancy more than 12 weeks
15. Stable breathing more than 5 minutes
Exclusion Criteria:
1. Complete obstruction of main portal vein
2. Pregnant and/or breastfeeding woman
3. Previous upper abdominal RT history
4. Uncontrolled active co-morbidity
5. Another primary cancer history within 2 years
6. Uncontrolled ascites or hepatic encephalopathy
7. Connective tissue disease which known as radiation hypersensitivity
8. Uncontrolled moderate to severe gastroduodenal ulcer or esophagogastric varicesReferences
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