Lung Cancer
Conditions
Interventions
Experimental group:Chemotherapy + Radiotherapy
Irinotecan Hydrochloride Liposome : 50mg/m2 on day 1
repeated every 3 weeks for a total of four cycles.
Carboplatin AUC = 4 on day 1
repeated every 3 weeks for a total of four cycles. Researchers may also choose other platinum - based drugs according to the patients condition. Radiotherapy starts 2 - 3 weeks after the completion of
Sponsors
The 901st Hospital of the PLA Joint Logistic Support Force
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient had good compliance, could understand the research process of this study, and signed the written informed consent form; 2. Age >=60 years old; 3. Confirmed as small cell lung cancer by histology or cytology; 4.ECOG 0-2 points; 5. The expected survival time is greater than 3 months; 6. Have appropriate organ function, as defined below :(Those who have completed hematological and blood biochemical tests within 14 days before enrollment and meet the following conditions. (1) Absolute neutrophil count (ANC) >= 1.5×10^9/L (2) Hemoglobin >=90g/dL (3) Platelet count (PLT) >= 100×10^9/L (4) Total bilirubin =50mL/min (24-hour urine collection or calculation using the Cockroft-Gault method). 7. Women who are not pregnant or breastfeeding; During the study period and within 6 months after the end of the study treatment, women/men of childbearing age should take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Diagnosed as having pulmonary fibrosis or interstitial pneumonia within 28 days before enrollment; 2. Active infection If there is HIV infection or chronic HBV/HCV in the active stage (such as HBV DNA>=10^4 copies or >=2000IU/mL), antiviral liver-protecting treatment should be administered first. Only when HBV DNA is less than 10^4 copies or less than 2000IU/mL can the patient be enrolled. And continue to take antiviral drugs, monitor liver function and HBV viral load; 3. Severe concomitant diseases: such as those with diabetes that cannot be well controlled by hypoglycemic drugs, clinically severe (i.e., active) heart disease, renal failure, liver failure, uncontrolled epilepsy, history of central nervous system diseases or mental disorders, hemorrhagic peptic ulcers, intestinal paralysis, intestinal obstruction, etc. 4. Severe diarrhea; 5. Severe mental disorders. 6. Known allergies to irinotecan liposomes and platinum-based drug-related components; 7. Patients who were assessed by the researchers as unsuitable for the trial 8. Had participated in other clinical researchers within 4 weeks before enrollment; 9. Patients whom the researchers consider unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression-free Survival;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactLu Husheng
The 901st Hospital of the PLA Joint Logistic Support Force
Outcome results
None listed