NSCLC
Conditions
Interventions
Experiment group:Kangai injection 60ml ivgtt D1-14 Q21d,combined with platinum-based first-line chemotherapy,Q21d
Control group:platinum-based first-line chemotherapy (GP or TP chemotherapy regimens), Q21d
Sponsors
Guang’anmen Hospital affiliatied to China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosis of IIIB~IV stage NSCLC according to pathology or cytology; (2) At least 1 objectively measurable Tumor lesion (iconography: CT, MRI), the assessable lesion can be measured accurately, maximum diameter>=20mm or >=10mm (by Spiral CT); (3) ECOG status0-2; (4) Expected survival >=3 months; (5) Aged from 18 to 75 years; (6) ANC>1.5*10^9/L, Platelet count>100*10^9/L, Hb>9.0g/dl, BIL at normal level or < 1.5 x ULN, AST (SGOT)ALT (SGPT) < 2.5 * ULN(< 5 *ULNif with liver metastases)SCr< 1.5 * ULN; (7) Signed informed consent, with good compliance.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women,psychotic patient; (2) Only with immeasurable lesions such as pleural effusion,pulmonary lymphangitic carcinomatosis, ascites, peritoneal cancer lesions, diffuse hepatic involvement, bone metastasis; (3) Patients with severe,uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy; (4) using other experimental drugs or paticipate in other clinical trials at the same time; (5) patients allergic to the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate (RR), Disease Control Rate (DCR);Adverse Reactions, progression-free survival (PFS), Clinical Symptoms, Quality of Life, Immunologic Function, Tumor Marker, Weight; | — |
Countries
China
Contacts
Public ContactHongsheng Lin
Outcome results
None listed