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

CTTQ

Status and phase: Unknown; Phase 4

Conditions: Liver Injury; Neoplasms

Treatments: Drug: Magnesium Isoglycyrrhizinate Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01802996

MAGIC-301

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,040 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,040 participants in 2 patient groups

Arm I

Experimental group

Description:

Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5

Treatment:

Drug: Magnesium Isoglycyrrhizinate Injection

Arm II

No Intervention group

Description:

Only chemotherapy