Advanced solid tumor
Conditions
Interventions
treatment group:Qingzao Gegen Yin 30ml/ bag, twice a day, 1 bag/time, po
matched group:Placebo is the same formulation and dosage of Qingzao Gegen Yin excipients, the packaging of the two is the same
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. During the treatment period, other treatments for liver damage were not accepted except Tianqingganmei combined with Yishanfu treatment. 2.KPS=60 points, expected survival =6 months: 3. Normal mental consciousness, can correctly understand the content of the quality of life scale, depression, anxiety scale questionnaire; 4. The patient's laboratory test results were consistent; • Liver function: ALT, AST =1.5×ULN or total bilirubin =1.5×ULN. • Renal function: creatinine = 1.5×ULN. • Cardiac function: Left ventricular ejection fraction (LVEF) = 40% • Coagulation function: fibrinogen = 1.0g/L, activated partial thromboplastin time (APTT) = 1.5×ULN, prothrombin time (PT) = 1.5×ULN.
Exclusion criteria
Exclusion criteria: 1. Patients with severe emaciation (body mass index less than 17), severe anemia (Hb less than 60g/L), and cachexia; There are serious difficulties in eating and can not be oral jujube kudzu drink 2. The patient has a central nervous system lesion (e.g. brain edema, need for hormonal intervention, or progression of brain metastases). 3. Patients had uncontrollable infectious diseases within 4 weeks before enrollment. (<CTCAE Class 2 genitourinary system infections and upper respiratory tract infections, except EBV infections). Positive for human immunodeficiency virus (HIV) antibodies; Syphilis test positive. 4. The patient has a central nervous system lesion (e.g. brain edema, need for hormonal intervention, or progression of brain metastases). 5. Patients with uncontrolled infectious disease or active autoimmune disease within 4 weeks prior to enrollment. 6. Patients had received prophylactic live vaccine or attenuated live vaccine within 4 weeks prior to screening. 7. The patient had participated in other clinical studies within 4 weeks prior to screening. 8. Patients with a history of severe drug allergy or penicillin allergy, known to be allergic to cordycepin. 9. The patient has substance abuse/addiction. 10. According to the investigator's judgment, the patient had other conditions that were not suitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function AST and ALT levels will be below degree II; | — |
Secondary
| Measure | Time frame |
|---|---|
| Piper score change, KPS score; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Shanghai Sixth People's Hospital
Outcome results
None listed