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

Study Overview
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Brief Summary
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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.

Detailed Description
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Total subjects: 2040, experimental group of 1360 patients, control group of 680 patients. According to the study subjects receiving antineoplastic chemotherapy, subjects are stratified randomize.

Official Title
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A Randomized, Controlled, Multi-center Collaborative Study to Evaluate the Efficacy of Magnesium Isoglycyrrhizinate Injection in the Prevention of Antineoplastic Chemotherapy Related Acute Liver Injury

Conditions
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Neoplasms, Liver Injury

Intervention / Treatment
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* Drug: Magnesium Isoglycyrrhizinate Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18-75 years; Patients with malignant tumor accord with chemotherapy indication, candidate to a chemotherapy treatment, disease is not restricted; 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; ECOG≤2; Estimates survival time≥3 months; TBIL≤1.0×ULN, ALT、AST≤1.0×ULN; blood examination, uronoscopy, stool examination, renal function tests and electrocardiogram are normal; Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks). Exclusion Criteria: Patients with partial liver radiotherapy; Hepatitis B or C virus replication in the state, the patient will need antiviral therapy; Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder; Patients combined with cellular immune therapy; 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; Pregnancy, or patients during breast feeding; Patients have known hypersensitivity to Glycyrrhizin; Patients are participating, or have participated in other Clinical studies of new drugs within 4 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5 | Drug: Magnesium Isoglycyrrhizinate Injection<br>* 200mg IV on day 1-5<br>* Other names: 2005S07127;|
| No Intervention: Arm II<br>Only chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of liver injury | anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT>ULN | 0-15 days |