small cell lung cancer(SCLC)
Conditions
Interventions
Experiment group :Niraparib in combination with Anlotinib
Sponsors
Jilin Provice Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily joined the study and signed informed consent; 2.Aged 18 to 70 years (inclusive), gender is not limited; 3.Histologically confirmed small cell lung cancer; 4.Systemic chemotherapy that has previously received at least one line regimen, followed by disease progression or recurrence; 5.Prior treatment with anti-PD-L1 antibodies is allowed; 6.According to the RECIST 1.1 standard, there is at least one measurable target lesion; 7.ECOG physical score 0-2 points; 8.Expected survival time >= 3 months; 9.Consent to collect blood samples and tumor tissue samples for subsequent biomarker analysis; 10.Has good organ function, including: (1)Absolute neutrophil count >=1,500/µL; (2)Platelets >=125,000/µL; (3)Hemoglobin >=10 g/dL; (4)Serum creatinine =40years and 12 months.; 12.Is able to adhere to the protocol; 13.Has recovered from previous chemotherapy induced toxic side effects to <= grade 1 CTCAE or basal level, apart from <= grade 2 CTCAE peripheral neuropathy or hair loss symptoms at steady state.
Exclusion criteria
Exclusion criteria: 1.Has a known hypersensitivity to the active or inactive ingredients of niraparib or compound which has similar chemical structure to Niraparib; 2.Has a known hypersensitivity to the active or inactive ingredients of Anlotinib or compound which has similar chemical structure to Anlotinib; 3.Has symptomatic uncontrolled brain or leptomeningeal metastasis; 4.Major surgery or chemotherapy within 3 weeks of starting the study or patient has not recovered from any effects of the surgery; 5.Receive palliative radiotherapy encompassing > 20% of the bone marrow within 1 week of entering the study; 6.Patient with high risk of hemoptysis (e.g. bronchiectasis, uncured tuberculosis); 7.Be diagnosed any invasive cancer other than SCLC(apart from cured basal cell carcinoma, superficial bladder tumor and cervical carcinoma in situ) within 5 years prior to study enrolment; 8.Patient must has any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 9.Has a serious or uncontrolled disease, including but not limited to: (1)Uncontrollable nausea and vomiting, inability to swallow drug, any gastrointestinal disorders that may interfere with drug absorption and metabolism; (2)Active viral infections include human immunodeficiency virus (HIV antibody positive), hepatitis B HBV (Hbs Ag-positive with HBV-DNA>=103 copies/mL or >=500 IU/ mL), hepatitis C (anti-HCV positive and/or HCV RNA positive combined with clinical determination), etc; (3)Uncontrolled grand mal epilepsy, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders that may affect the subject's ability to sign informed consent; (4)Immunodeficiency (other than splenectomy), or other diseases that researchers believe may expose subjects to a high risk of toxicity. 10.Have a bleeding tendency and a history of thrombus: (1)Any bleeding event of CTCAE 5.0 grade 2 occurred within 3 months prior to screening, or CTCAE 5.0 grade 3 or above occurred within 6 months prior to screening; (2)There was a history of gastrointestinal bleeding or a definite tendency of gastrointestinal bleeding within 6 months before screening. For example: esophageal varicose veins with bleeding risk, local active ulcer lesions, or fecal occult blood; (3)Has active bleeding or abnormal coagulation function, has a bleeding tendency or is receiving thrombolytic or anticoagulant therapy; (4)Subjects will be treated with anticoagulant medication such as warfarin or heparin; (5)Subjects need to take long-term antiplatelet therapy (e.g. aspirin, clopidogrel); (6)Thrombosis or embolism events in the past 6 months, e.g. cerebrovascular accident (including transient ischemic attack), pulmonary embolism. 11.History of severe cardiovascular disease: (1)NYHA (New York Heart Association) Grade 3 and 4 congestive heart failure; (2)Patients with unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within the preceding 12 months were screened; (3)Arrhythmias requiring therapeutic intervention (subjects taking beta-blockers or digoxin can be included); (4)Valvular heart disease with CTCAE 5.0 >=2; (5)Poor control of hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg). 12.Other abnormal laboratory tests: Hyponatremia (sodium < 130 mmol/L); Baseline serum potassium <3.5 mmol/L (potassium supplementation can be used to restore serum potassium above this level before entering the study); Thyroid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactCheng Ying
Jilin Provice Cancer Hospital
Outcome results
None listed