Advanced solid tumor
Conditions
Interventions
The Icaritin combination group:The conventional regimen combined with Icaritin treatment
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients aged =18 years; 2) Histologically or cytologically confirmed patients with advanced solid tumors; 3) Those without severe organic lesions in heart, lungs, liver and kidneys, with hematology tests meeting the following criteria: ? Complete blood count: (neither transfusion of blood or blood products, nor use of hematopoietic stimulating factors within 14 days) ? Hb = 90 g/L; ? NEUT = 1.5 × 10E9/L; ? PLT = 80 × 10E9/L; ? Biochemical tests: ? ALB = 29 g/L; (no transfusion of albumin or blood products) ? Both ALT and AST = 2.5 × ULN; for patients with HCC or liver metastasis, both ALT and AST = 5 × ULN; TB = 1.5 × ULN; ? CREA = 1.5 × ULN; 4) Those with anticipated survival time = 3 months; 5) Those who are cooperative to observe adverse events (AEs) and efficacy; 6) Patients who have signed informed consent forms (ICFs); 7) Those with ECOG score = 1; and 8) Child-bearing women with negative pregnancy tests.
Exclusion criteria
Exclusion criteria: 1) Patients who are allergic to flavonoids; 2) Patients with a history of thrombotic diseases; 3) Patients with unrecovered rheumatic immunologic diseases; 4) Those who have any uncontrollable clinical problems (e.g., severe mental, neurologic, cardiovascular and respiratory diseases) or active infections which have significant effects on clinical trial; 5) Those with CNS metastases or neoplasm invasiveness (except for patients who are in stable and good condition) or a variety of mental disorders; 6) Patients who have active upper digestive tract ulcer or others affecting drug absorption, distribution, metabolism or clearance; 7) Patients complicated with other malignancies; and 8) Patients who are considered as not eligible to be enrolled in the trial by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of cytokines before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DOR;DCR;PFS;TTP;OS;QOL; | — |
Countries
China
Contacts
Public ContactWeihong Zhao
Chinese PLA General Hospital
Outcome results
None listed