SCLC
Conditions
Interventions
Sponsors
The Second Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically (histological or cytological) confirmed ED-SCLC patients (according to WHO 2015 classification); 2. No progression after 4-6 cycles of first-line EP/IP/CE regimen or other platinum-containing regimens; 3. Age 18-70 years old, gender is not limited; 4. =28 days before the first study drug, CT or MRI scan, with at least one evaluable and measurable target lesion (RECIST v1.1); 5.PS score: 0-2; 6. Expected survival period = 3 months; 7. Good organ function, including: (1) Neutrophil count =1.5x10^9/L; (2) Platelets=100x10^9/L; (3) Hemoglobin=100g/L; (4) Serum creatinine = 1.5 times the upper limit of normal (ULN), or creatinine clearance rate = 60 mL/min (calculated according to the Cockcroft-Gault formula); (5) Total bilirubin=1.5 times ULN or direct bilirubin=1.0 times ULN; (6) AST and ALT = 2.5 times ULN, and liver metastasis must be = 5 times ULN; (7) Left ventricular ejection fraction (LVEF) = 50%. 8. Female subjects of childbearing age have negative pregnancy test results when they are enrolled. Enrolled women of childbearing age and men with fertile partners must commit to adequate and effective contraception or abstinence from the start of the study to the end of the study and for 6 months after the last dose of the study drug. Alternatively, women enrolled in this study were women of infertility, defined as: women undergoing surgical fertilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or women = 60 years of age, Or =40 and <60 years old, menopause for more than 12 months; 9. Ability to comply with the programme; Toxic effects from any previous chemotherapy have recovered to =CTCAE 5.0 Grade 1 or baseline, except for symptomatic stable sensory neuropathy or alopecia = CTCAE 5.0 Grade 2.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to fluzoparib or the active or inactive ingredients of drugs with similar chemical structures to fluzoparib; 2. Received major surgery within 3 weeks before the start of the study, or any surgical effect that has not recovered after surgery; 3. Received radiation therapy for target lesions within 4 weeks before starting the study drug; received palliative radiation therapy with >20% bone marrow 1 week before enrollment; 4. Suffering from other malignant tumors other than small cell lung cancer within 5 years before enrollment (except in situ cervical cancer, basal cell carcinoma, and superficial bladder tumor that have been radically treated); 5. Previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 6. Suffering from serious or uncontrolled diseases, including but not limited to: (1) Uncontrollable nausea and vomiting, inability to swallow study drugs, and any gastrointestinal diseases that may interfere with drug absorption and metabolism; (2) Active viral infections such as human immunodeficiency virus (HIV antibody positive), hepatitis B HBV (Hbs Ag positive, and HBV-DNA = 103 copies/ml or = 500 IU/ml), hepatitis C (anti-HBV) - HCV positive and/or HCV RNA positive combined with clinical judgment), etc.; (3) Uncontrolled grand mal epilepsy, unstable spinal cord compression, superior vena cava syndrome or other mental disorders that affect the subject's signed informed consent; (4) Immunodeficiency (except splenectomy), or other diseases that researchers believe may expose subjects to high risk toxicity. 7. History of severe cardiovascular disease: (1) NYHA (New York Heart Association) grade 3 and 4 congestive heart failure; (2) Suffering from unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within 12 months before screening; (3) Arrhythmia requiring therapeutic intervention (subjects taking beta-blockers or digoxin can be enrolled); (4) CTCAE 5.0 = grade 2 valvular heart disease; (5) Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg). 8. Other laboratory abnormalities: (1) Hyponatremia (sodium <130 mmol/L); (2) Baseline serum potassium <3.5 mmol/L (before entering the study, potassium supplements can be used to restore serum potassium to above this level); (3) Abnormal thyroid function, and the thyroid function cannot be maintained within the normal range with drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;OS;AEs; | — |
Countries
China
Contacts
Public ContactYu Xiaoming
Outcome results
None listed