Extensive stage Small Cell Lung Cance
Conditions
Interventions
Single arm:Dianhydrodulcitol for Injection
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Pathologically confirmed ES-SCLC patients (VALG staging according to American Legion lung Cancer Association, see Appendix I); (2) Patients who failed in previous second-line treatment. Treatment failure was defined as progression or recurrence within 6 months after treatment. (3) Did not receive chemotherapy or radiotherapy within 4 weeks before the first administration, and did not receive immunotherapy within 3 weeks before the first administration. For subjects who had received targeted therapy, elution exceeded 5 half-lives of treatment drugs before enrollment. (4) Patients aged >= 18 years; (5) Having at least one assessable tumor lesion according to recistVl.L (see Appendix II); (6) ECOG score is 12 weeks; (8) All kinds of laboratory tests within 1 week before the first administration were basically normal (the standard was the normal value of laboratories in each research center, and no blood transfusion, NO G-CSF and no drug correction were used within 14 days before the screening): Routine blood tests: 1) Hemoglobin >= 9 g/dL; 2) Absolute value of neutrophils >= 1.5 x 10^9 /L; 3) Platelet >= 80 x 10^9/L; Blood biochemical examination (no albumin injection within 14 days) : 1) Total bilirubin = 45mL/min; Coagulation function test: international standardized ratio 50%; (10) Male or female patients agree to use narU approved contraceptive methods for effective contraception or abstinence during the study period and for 6 months after the last administration; (11) Informed consent has been signed and the study can be completed in accordance with the requirements of the pilot program.
Exclusion criteria
Exclusion criteria: (1) patients with active tuberculosis; Patients with significant hemoptysis within 1 month, or with hemoptysis of half a teaspoon (2.5 ml) or more per time; Patients with high suspicion of interstitial pneumonia; or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity; (2) Pericardial effusion of clinical significance; (3) Moderate pleural effusion or ascites; (4) Patients with severe diseases (CTCAEV5.0 rating >= 3) or any other diseases deemed unfit for the study by the researcher, including but not limited to: severe heart disease, cerebrovascular disease, diabetes mellitus with poor drug control, hypertension with poor drug control, severe infection, active gastrointestinal ulcer, and mental illness with difficulty in control; (5) Accompanied by brain metastasis, spinal cord compression, cancerous meningitis with clinical symptoms, or other evidence showing that the brain and spinal cord metastasis of the patient has not been controlled, and is not suitable for inclusion according to the judgment of the researchers; (6) Patients with uncontrolled bone metastasis; (7) Patients with other malignant tumor diseases other than those treated in the study (exceptions include: malignant tumors that are cured and have not recurred within 5 years prior to study inclusion; Complete resection of basal cell and squamous cell skin cancer; Complete resection of any type of carcinoma in situ); (8) Persons with positive human immunodeficiency virus test results, or persons with untreated active hepatitis; (9) The patients who had received the previous treatment of Weizhil; (10) Patients known to be allergic to study drugs or other excipients; (11) Patients who have not recovered from the toxicity of previous treatment (toxicity >= 2 at screening, except hair loss); (12) Patients with poor compliance; (13) Screening for any clinical subjects who had participated in the previous 12 weeks; (14) The investigator considers it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactZhan-Wen Huang
Outcome results
None listed