Liver injury during first- or second-line combined immunotherapy (ICIs) and chemotherapy for anticancer treatment
Conditions
Interventions
Experimental group:Intravenous infusion of magnesium isoglycyrrhizinate injection
Historical control group:Retrospectively collect cases of anti-tumor treatment with ICIs combined with chemotherapy in the real world
Sponsors
HenanCancerHospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, regardless of gender; 2. Estimated survival time > 3 months; 3. Patients with solid tumors confirmed by definite cytological or histopathological, or imaging diagnosis; 4. Anti-tumor regimens: first-line or second-line immune checkpoint inhibitors (ICIs) combined with chemotherapy; 5. Expected ICIs combined with chemotherapy >=4 cycles; 6. ALT and AST<=2×ULN, TBIL<=1×ULN and ALP<= 1.5×ULN before anti-tumor treatment; 7. Enrollment was at least 3 weeks after the end of the last antineoplastic therapy (except long-term oral monotherapy with a small molecule targeted agent or local radiotherapy without liver involvement).
Exclusion criteria
Exclusion criteria: 1. Patients with hepatitis B or C virus replication, HBV-DNA/HCV-RNA higher than the upper limit of the detection range, or using antiviral drugs; 2. Patients with severe hypokalemia (K<2.5mmol/L), hypernatremia, heart failure (Killip class or NYHA class III and above), renal failure (renal function class III and above) and uncontrolled severe hypertension (hypertension class III and above); 3. Other anti-tumor treatments such as radiotherapy and cellular immunotherapy involving the irradiated liver are being combined; 4. Use of magnesium isoglycyrrhizinate or other oral or intravenous hepatoprotective drugs within two weeks before enrollment, or other drugs that may affect the efficacy of the study; 5. Liver injury of grade 3 or above within 3 months before enrollment (CTCAE5.0); 6. Participated in other clinical trials and used study drugs within 4 weeks; 7. Allergic or intolerant to glycyrrhizic acid preparations; 8. Pregnant or lactating women; 9. Known to be seropositive for human immunodeficiency virus (HIV), or to have AIDS or infectious syphilis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of liver injury; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Incidence rate of adverse events (such as immune-related skin toxicity, gastrointestinal toxicity, pulmonary toxicity, endocrine toxicity, etc.);Patient tumor treatment compliance (treatment interruption, dose reduction, treatment plan modification);Severity of liver damage;The time from the initiation of anti-tumor treatment to the occurrence of liver damage; | — |
Countries
China
Contacts
Public ContactSuxia Luo
HenanCancerHospital
Outcome results
None listed