Evaluate the Efficacy of Magnesium Isoglycyrrhizinate in the Prevention of Chemotherapy Related Acute Liver Injury

• Status: Unknown status
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This purpose of this study is to evaluate the evaluate the efficacy of Magnesium Isoglycyrrhizinate Injection in the prevention of antineoplastic chemotherapy related acute liver injury.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cttq

Criteria

Inclusion Criteria:

1. Male or female aged 18-75 years;

2. Patients with malignant tumor accord with chemotherapy indication, candidate to a chemotherapy treatment, disease is not restricted;

3. Accorded with the following chemotherapy plan: included cis-platinum, ≥60mg/m2/course; included oxaliplatin, ≥85mg/m2/course; included cyclophosphamide, ≥600mg/m2/course; included gemcitabine, ≥60mg/m2/course;

4. ECOG≤2;

5. Estimates survival time≥3 months;

6. TBIL≤1.0×ULN, ALT、AST≤1.0×ULN; blood examination, uronoscopy, stool examination, renal function tests and electrocardiogram are normal;

7. Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks).

Exclusion Criteria:

1. Patients with partial liver radiotherapy;

2. Hepatitis B or C virus replication in the state, the patient will need antiviral therapy;

3. Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;

4. Patients combined with cellular immune therapy;

5. Within 2 weeks of application or currently possible applications of drugs(polyene phosphatidylcholine, reduced glutathione, tiopronin and other hepatoprotective and choleretic drugs), interference with the study;

6. Pregnancy, or patients during breast feeding;

7. Patients have known hypersensitivity to Glycyrrhizin;

8. Patients are participating, or have participated in other Clinical studies of new drugs within 4 weeks.