Small Cell Lung Cancer
Conditions
Interventions
single arm:liposomal paclitaxel combined with Anlotinib Hydrochloride
Sponsors
Shandong Provincial Cancer Hospital affiliated to Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participants voluntarily joined the study, signed informed consent, and had good compliance and follow-up; 2. Aged 18 to 70 years; 3. SCLC by pathology; 4. The objective imaging of Patients must have is PD; 5. ECOG PS 0~2 ?; 6. Estimated survival duration more than 8 weeks; 7. Patients must be agreed to take contraceptive measures during the trial and 24 weeks after the last administration of the test drug; 8. Major organs function levels meet the following criteria: (1) The blood routine examination standards must be in accordance with: WBC =3.0 × 109/L, ANC= 1.5 × 109/L, PLT=100 × 109/L, HGB =9.0 g/dL; (2) Patients without liver metastasis: AST=2.5 x ULN, ALT=2.5 x ULN; Liver metastatic patient: ALT and AST<5 x ULN, TBIL =1.5 x ULN, ALB =3 g/dL; (3) Creatinine is equal to or less than 1.5 times of the normal upper limit or CrCl =40 mL/minute, UPRO is negative. (4) International normalized ratio =1.5xULN, and activated partial thromboplastin time=1.5 xULN. 9. Patients starting treatment need not less than 21 days from the last cycle of first-line chemotherapy (first day), but not more than 42 days.
Exclusion criteria
Exclusion criteria: 1. Combined with NSCLC. 2. Radiotherapy has not completed 4 weeks before joining into the group. The patient have not recovered from the acute toxic reaction to the treatment. 3. There's a third space of clinical symptoms. Uncontrollable hydropericardium, pleural effusion and peritoneal effusion. 4. Interstitial pneumonia, drug-induced pneumonia, radiation pneumonia requiring steroid therapy or clinically active pneumonia. 5.Tuberculosis (TB) or a history of active tuberculosis infection within 48 weeks. 6. Toxicity caused by cancer treatment cannot recover in short term. 7. During the first 24 weeks, patients had the following medical history: pepticulcer, esophagitis and gastritisinflammatory bowel disease and diverticulosisintestinal fistulatracheoesophageal fistulaperitoneal abscess. 8. Allergic reactions to drugs or excipients. 9.Patien have tumor within five yearsexcept cervical carcinoma in situ, basalcellcarcinoma and squamous cell cancer, localized prostate cancer after radical surgery, catheter carcinoma in situ after radical surgery. 10. Patien have Mental illness, alcoholism, inability to quit smoking, drug taking or substance abuse. 11. HBsAg positive and HBV DNA test value exceeds the upper limit of normal value (1000 c /ml or 500IU/ml), or HCV positive; HIV positive and Acquired Immune Deficiency Syndrome (AIDS). 12. Participated in clinical trials of other drugs within four weeks. 13. The researchers judged other conditions that could affect clinical research and the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DOR;SAE; | — |
Countries
China
Contacts
Public ContactZhehai Wang
Shandong Provincial Cancer Hospital
Outcome results
None listed