Clinical trial · Interventional
Clinical Trial of Radiotherapy in Treating Primary Hepatocellular Carcinoma
NCT03614546CI-TRIAL-00036682unknownN/AClinicalTrials.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)
The subjects of primary hepatocellular carcinoma diagnosed pathologically or clinically will be grouped according to the size, location, number and function of the liver, and respectively received Intensity-modulated Radiation Therapy (IMRT), Stereotactic Body Radiation Therapy (SBRT), Transarterial chemoembolization (TACE) or surgery.
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 |
|---|---|---|---|
| Primary Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hepatectomy | Procedure | — | UNRESOLVED |
| IMRT | Radiation | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- OTHER
- label
- A(surgery) group
- description
- Hepatectomy
- interventionNames
- Procedure: Hepatectomy
- type
- EXPERIMENTAL
- label
- B1(SBRT) group
- description
- Stereotactic Body Radiation Therapy(SBRT), 40-55Gy/5-6F
- interventionNames
- Radiation: SBRT
- type
- EXPERIMENTAL
- label
- B2a(TACE+ IMRT ) group
- description
- First,treat with intensity modulated radiation therapy (IMRT),50Gy/25F/5W, 4 weeks after IMRT,treat with transcatheter arterial chemoembolization(TACE) 2-4 times
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Meeting the diagnosis criteria of primary hepatocellular carcinoma: (1) primary hepatocellular carcinoma diagnosed by histology or cytology; (2) primary hepatocellular carcinoma diagnosed clinically (referring to the standard of diagnosis and treatment of primary hepatocellular carcinoma, version 2017); 2. Stage Ia-IIIa disease (referring to the standard of diagnosis and treatment of primary hepatocellular carcinoma, version 2017). 3. Child-Pugh score class A or B without encephalopathy; 4. Age between 18-80 years old; 5. At least one measurable lesion according to the 1.1 version of response evaluation criteria in solid tumors (RECIST). 6. ECOG(Eastern Cooperative Oncology Group) performance status of 0-2 at enrollment(subjects with ECOG performance status of 2 did not deteriorate in the last 2 weeks). 7. Written informed consent for the trial. 8. Be Willing and able to comply with planned visits, treatment plans, laboratory tests and other test procedures. 9. Have a life expectancy greater than 3 months judged by investigators; Exclusion Criteria: 1\. History of upper abdominal radiotherapy; 2. History of liver transplantation; 3. Abnormal laboratory results as follows: 1. abnormal hematology results, including hemoglobin less than 8.5 g/dL (no blood transfusion within 14 days before); neutrophils less than 1.5×109 /L or platelets less than 60×109 /L (no blood transfusion or growth factor was used within 7 days before); 2. abnormal liver function: total bilirubin \>3×upper limit of normal (ULN); aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \> 5×ULN; 3. abnormal renal function: serum creatinine \>1.5×ULN, or creatinine clearance rate (CrCl) \< 60 mL/min according to Cockcroft-Gault formula. 4. international normalized ratio (INR) \> 2.3 (according to the revised Child-Pugh grading Guide); 5. the calibration values of potassium, sodium, magnesium or calcium not within the normal range, and have clinical significance according to the judgment of the primary investigator. 4\. History of other cancers besides primary hepatocellular carcinoma, with the exception of cured non-melanoma skin cancer, in situ cervical cancer, or other cancers received cured treatment and showed no signs of disease in at least 3 years. 5\. Metastases to central nervous system (CNS) or brain; 6. Significant gastrointestinal bleeding occurred within 4 weeks before entering the trial. 7\. Cardiac dysfunction as demonstrated by any of the following conditions: 1. recent echocardiography revealed a left ventricular ejection fraction \< 45%. 2. severe arrhythmia; 3. unstable angina pectoris; 4. New York Heart Association III and IV congestive heart failure; 5. myocardial infarction occurred in the last 12 months before admission. 6. pericardial effusion; 8. Uncontrolled hypertension after standard treatment (blood pressure not stably below 150/90 mmHg) 9. Known human immunodeficiency virus (HIV) infection; 10. Pregnant or during lactation period, or is fertile male and female who is not willing or unable to take birth control/contraception to prevent pregnancy during the period between 2 weeks before radiation and 1 month after radiation; 11. Substance abuse, other acute or chronic physical or mental illness or abnormal laboratory examination that might increase the risk of participation judged by investigator. 12\. Previous cancer treatment related toxicities that did not return to baseline or grade 0-1 (except for hair loss and peripheral neuropathy). 13\. Any physical condition or illness that might increase the risk of participation judged by investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.