Advanced digestive trac tmalignant tumor
Conditions
Interventions
A:Best support treatment+Single-agent oral chemotherapy
B:Best support treatment+Single-agent oral chemotherapy + Kushen Injection
Sponsors
Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Before the start of the study, All patients have been fully understood and the willingness to sign the informed consent; (2) Age from 18 to 75 years old, Sex unlimited; (3) stage IV digestive tract tumors diagnosis must be proved by pathology; (4) According to RECIST (version 1.1), At least 1 objectively measurable Tumor lesion (iconography: CT, MRI), the assessable lesion can be measured accurately, maximum diameter larger than at least 10mm (Malignant lymph nodes on CT scans short diameter larger than at least 15 mm); (5) Eastern Cooperative Oncology Group (ECOG) performance status less than 3; (6) The function of each organ is basically normal: ANC more than 1.5*10^9/L, Platelet count more than 100*10^9/L, Hb more than 9.0g/dl, BIL at normal level or more than 1.5*ULN, AST (SGOT), ALT (SGPT) less than 2.5*ULN (less than 5*ULN, if with liver metastases); SCr less than 1.5*ULN; (7) Expected survival time must more than 3 months.
Exclusion criteria
Exclusion criteria: (1) Ever received compound Kushen therapy within 2 weeks; (2) Pregnancy or lactation women; (3) Only with immeasurable lesions such as pleural effusion,pulmonary lymphangitic carcinomatosis, ascites, peritoneal cancer lesions, diffuse hepatic involvement, bone metastasis; (4) Patients with severe,uncontrolled organic lesions or infection, such as decompensated heart, lung,kidney failure can lead to tolerance of chemotherapy; (5) participating in another clinical study or have participated in another clinical study within 30 days; (6) Aallergic to the testing compound; (7) Had a history of serious Psychological or Psychiatric disorders, Drug addiction or Alcohol dependence; (8) To be expected with poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Symptoms;Quality of Life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rates;Progression-free surial;Overall survival;The pain;Tumor markers;weight;ECOG PS; | — |
Countries
China
Contacts
Public ContactHongsheng Lin
Outcome results
None listed