Overview

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.