Clinical trial · Interventional
Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer
A Randomized, Controlled Study to Evaluate the Efficacy and Significant of the Anti-virus Therapy for the Unresectable Hepatitis B Virus-related Primary Liver Cancer
NCT00824707CI-TRIAL-00021589completedN/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)
This study is working to research the efficacy and significant of the anti-virus therapy in the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish treatment standards of anti-virus therapy in PLC.
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 Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional therapy | Drug | — | UNRESOLVED |
| Entecavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- anti-virus therapy
- description
- 100 HCC patients will be allocated to receive anti-virus therapy.
- interventionNames
- Drug: Entecavir
- type
- ACTIVE_COMPARATOR
- label
- conventional therapy
- description
- 100 patients will undergo conventional therapy
- interventionNames
- Drug: conventional therapy
Primary outcomes (1)
- measure
- time-to-progression(TTP)
- timeFrame
- 1,2 and 3 years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Identify patients with PLC in accordance with the clinical diagnostic criteria of PLC.Patients with PLC shall be diagnosed with or without pathology. It is not appropriate to perform liver resection operation. 2. serum positive HBsAg≥6 months. 3. Criteria of liver function: Child A or B level, serum total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 10 times the upper limit of normal value. 4. hemoglobin≥8.5g/dl, PT-INR≤2.3 or PT\>6 seconds of normal value. 5. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. 6. Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent. Exclusion Criteria: 1. Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction, which may affect the treatment of liver cancer. 2. Patients with other diseases which may affect the treatment mentioned here. 3. Patients with medical history of other malignant tumors. 4. Subjects participating in other clinical trials. 5. Women in pregnancy and breast-feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.