Clinical trial · Interventional
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)
A Prospective Randomized Trial Comparing Ulinastatin's Drug Protection in Hepatocellular Carcinoma(HCC)Patients'Postoperative Hepatic Failure
NCT01643447CI-TRIAL-00021556completedN/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 purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that Ulinastatin can improve survival in HCC patients or not.
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 |
|---|---|---|---|
| Diammonium glycyrrhizinate | Drug | — | UNRESOLVED |
| Ulinastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Diammonium glycyrrhizinate
- description
- Conventional drugs protect liver
- interventionNames
- Drug: Diammonium glycyrrhizinate
- type
- EXPERIMENTAL
- label
- Ulinastatin
- description
- Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)
- interventionNames
- Drug: Ulinastatin
Primary outcomes (1)
- measure
- the overall survival rate of each group
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients \> 35 years and \<=55 years of age. 2. confirmed case (patients with HCC) 3. Tumors can be radical removed and resection volume was 50% to 70%. 4. Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value. 5. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³. 6. Karnofsky Performance Score performance over 60. 7. Patients who can understand this trial and have signed information consent. Exclusion Criteria: 1. Patients who have undergone previous treatment by Ulinastatin. 2. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer. 3. Patients with other diseases which may affect the treatment mentioned here. 4. Patients with medical history of other malignant tumors. 5. Subjects participating in other clinical trials. 6. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C. 7. Patients would not sign the consent to the trial.
References
Publications (0)
Data not yet available
No reference posted for this study.