Small cell lung cancer
Conditions
Interventions
Test group:Dehydrated Dulcitol for Injection
Sponsors
Luoyang First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed ES-SCLC patients (according to the American Veterans Lung Cancer Association, VALG stage, see Appendix I); 2. Patients who have previously relapsed after first-line standard treatment; 3. Have not received chemotherapy or radiotherapy within 4 weeks before the first dose, and have not received immunotherapy within 3 weeks before the first dose. For subjects who have received targeted therapy, the drug has been eluted for more than 5 half-lives before enrollment; 4. Patients aged >=18 years old; 5. At least one evaluable tumor lesion according to RECIST v1.1 (see Appendix II); 6. ECOG score 12 weeks; 8. All kinds of laboratory tests are basically normal within 1 week before the first administration (standardized by the normal value of the laboratory of each research center, and no blood transfusion, no albumin transfusion, no use of G-CSF or G-CSF within 14 days before screening Corrected by other medicines): 9. Blood routine: hemoglobin >= 9 g/dL; absolute value of neutrophils >= 1.5x10^9/L; platelets >= 80x10^9/L; 10. Blood biochemistry: total bilirubin = 45 mL/min; 11. Coagulation function: international normalized ratio 50%; 13. Male or female patients agree to use medically approved contraceptives for effective contraception or abstinence during the study treatment period and within 6 months after the last dose; 14. Have signed the informed consent and be able to complete the study according to the requirements of the experimental protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with active pulmonary tuberculosis; or patients with obvious hemoptysis within 1 month, or patients with hemoptysis of half a teaspoon (2.5 ml) or more each time; patients with high suspicion of interstitial pneumonia; 2. Clinically significant pericardial effusion; 3. Moderate or more pleural effusion or ascites; 4. Patients with clinical symptoms of brain metastases, spinal cord compression, cancerous meningitis, or other evidence that the patient's brain and spinal cord metastases have not been controlled, and are judged by the investigator to be unsuitable for inclusion; 5. Patients with uncontrollable bone metastases; 6. Suffering from other malignancies other than the tumors treated in this study (exceptions include: malignancies that have been cured and have not recurred within 5 years prior to study entry; completely resected basal cell and squamous cell skin cancer; completely resected any type of carcinoma in situ); 7. Patients with positive human immunodeficiency virus test results, or patients with untreated active hepatitis; 8. Patients who have been treated with water dulcitol in the past; 9. Patients who are known to be allergic to study drugs or other excipients; 10. Patients who have not recovered from previous treatment toxicity (toxicity >= grade 2 at screening, except for alopecia); 11. Those who have participated in any clinical trial within 12 weeks before screening; 12. The researchers believe that it is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Duration of Response;Progression Free Survival;Karnofsky (Karnofsky, KPS, percentile) functional status score;Overall Survival;incidence of brain metastasis or progression of brain metastasis;occurrence time of brain metastasis or progression of brain metastasis;Adverse Event, Serious Adverse Event, Adverse Drug Reaction; | — |
Countries
China
Contacts
Public ContactWang Hongwei
Luoyang First People's Hospital
Outcome results
None listed