small cell lung cancer
Conditions
Interventions
Experimental Group:Adebrelimub+chemotherapy or targeted therapy
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: >18 years old, male or female; 2. Advanced stage small cell lung cancer (staged according to the Veterans Administration Lung Study Group, VALG) diagnosed by pathohistology or cytology combined with imaging; 3. Patients treated with adebrelimab in combination with etoposide and platinum in the first line; 4. In the opinion of the investigator there is still clinical benefit and no unacceptable toxicity from continued treatment with adebelizumab. 5. ECOG score of 0-1; 6. A measurable tumour target lesion (meeting RECIST 1.1 criteria); 7. Expected survival > 3 months; 8. Normal major organ function; a. Routine blood tests: Haemoglobin (Hb) >= 90g/L; Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L; Platelet (PLT) >= 100 x 10^9 /L; White blood cell count (WBC) >= 3.0 x 10^9 /L; b. Biochemical tests: Albumin transaminase (ALT) and albumin transaminase (AST) = 50 ml / min; c. Coagulation: Activated partial thromboplastin time (APTT), international normalised ratio (INR), prothrombin time (PT) =50%; 9. Women of childbearing potential must undergo a negative pregnancy test (ßHCG) prior to initiating treatment, and both women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose; 10. Patients voluntarily enter the study by signing an informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of or current concurrent other malignancies within 5 years, except cured carcinoma in situ of the uterine cervix, non-melanoma skin cancers and superficial bladder tumours [Ta (non-invasive tumours), Tis (carcinoma in situ) and T1 (tumour infiltrating basement membrane)]; 2. Known history of allergy to any of the study drugs; 3. Autoimmune disease and requiring hormonal therapy above 10 mg prednisone/day (or equivalent dose). 4. Active or uncontrolled severe pulmonary infection; 5. Uncontrolled pleural effusions, pericardial effusions, and peritoneal effusions requiring repeated drainage. 6. History of live attenuated vaccination within 28 days prior to the first study dose or expected live attenuated vaccination during the study; 7. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 8. Subjects who have previously received or are preparing to receive an allogeneic bone marrow transplant or solid organ transplant; 9. Medically uncontrollable hypertension, diabetes mellitus, class III-IV cardiac insufficiency (NYHA criteria); 10. Subjects with known central nervous system metastases and/or spinal cord compression; unless asymptomatic, or treated and stable, with no imaging evidence of new brain metastases or enlargement of brain metastases for at least 2 weeks after treatment for brain metastases, and who have discontinued steroids or completed study treatment with anticonvulsant medications for at least 14 days prior to initiation of study treatment; and 11. Active hepatitis (Hepatitis B reference: HBsAg positivity and HBV DNA test value above the upper limit of normal; Hepatitis C reference; HCV antibody positivity and HCV viral titre test value above the upper limit of normal); 12. Active bleeding, active ulcers, intestinal perforation, intestinal obstruction, within 30 days of major surgery; previous history of definite neurological or psychiatric disorders, including epilepsy or dementia, and subject has a known history of psychotropic substance abuse, alcoholism, or drug addiction; 13. Serious arterial or venous thrombotic events, such as deep vein thrombosis, pulmonary embolism, etc., within 3 months prior to the first dose of study treatment (with the exception of implantable IV ports, catheter-derived thrombosis, or superficial venous thrombosis, which are not considered ‘serious’ thromboembolisms). 14. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Duration of response;Overall survival;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactYuan Liang
Liaoning Cancer Hospital & Institute
Outcome results
None listed