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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


Phase 4
18 Years
75 Years
Not Enrolling
Both
Neoplasms, Liver Injury

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

The incidence of liver injury

Outcome Description:

anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT>ULN

Outcome Time Frame:

0-15 days

Safety Issue:

No

Principal Investigator

Qin Shukui, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The 81st hospital of PLA

Authority:

China: Food and Drug Administration

Study ID:

MAGIC-301

NCT ID:

NCT01802996

Start Date:

March 2013

Completion Date:

August 2014

Related Keywords:

  • Neoplasms
  • Liver Injury
  • Neoplasms

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