Small cell lung cancer
Conditions
Interventions
A group:Adebrelimab 1200 mg IV, Q3W, D1
apatinib, PO, 250 mg, QD
nabpaclitaxel, IV, 200 mg/m2, q3w
after four cycles, adebrelimab and apatinib were maintained until disease progression or intolerance.
B group:Adebrelimab 1200 mg IV, Q3W, D1
until disease progression or intolerance.
C group:Apatinib, PO, 250 mg, QD
after four cycles, apatinib was maintained until disease progression or intolerance.
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed small cell lung cancer patients; 2. First-line immune combined chemotherapy treatment progression, and PFS > 3 months; 3. At least one measurable lesion that meets RECIST 1.1 evaluation criteria; 4. Aged 18-75 years; 5. Life expectancy more than 3 months; 6. ECOG PS 0-1; 7. Laboratory parameters consistent with the study protocol, including: 1) hemoglobin (HB) = 90 g/L (no blood transfusion within 14 days before screening); 2) absolute neutrophil count (ANC) = 1.5 × 10 ^ 9/L; 3) platelet count (PLT) = 80 × 10 ^ 9/L; 4) bilirubin 45 ml/min (Cockcroft-Gault formula). 8) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 1.5 × ULN; 9) Others: lipase = 1.5 × ULN.Patients with lipase > 1.5 × ULN without clinically or radiologically confirmed pancreatitis may be enrolled; 10) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = 50%; 8. With my consent and signed informed consent form, willing and able to comply with scheduled visits, study treatment, laboratory tests, and other test procedures; 9. Female subjects of childbearing potential must have a serum pregnancy test performed within 72 hours before the first dose and have a negative result and are not breastfeeding, and willing to use a medically recognized highly effective contraceptive measure (e.g., intrauterine device, contraceptive pills, or condom) during the study and within 3 months after the last dose of adebelimumab/apatinib or 6 months after the last dose of nabpaclitaxel (whichever is longer); for male subjects with partners of childbearing potential, surgical sterilization is required, or agree to use an effective method of contraception during the study and for 3 months after the last dose of study, and sperm donation is not allowed during the study.
Exclusion criteria
Exclusion criteria: 1. Currently participating in interventional clinical study treatment, or receiving other investigational drugs or using investigational devices within 4 weeks before the first dose; 2. Previous treatment with anti-angiogenic drugs, such as apatinib, anlotinib, bevacizumab, etc.; 3. Previous treatment with paclitaxel or nabulin paclitaxel; 4. Received systemic systemic systemic treatment with Chinese patent medicines or immunomodulatory drugs with indications against lung cancer (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose, or received major surgical treatment within 3 weeks before the first dose; 5. Received solid organ or blood system transplantation; 6. Clinically symptomatic third space effusion, such as pericardial effusion, pleural effusion, and abdominal effusion requiring repeated drainage (e.g., once a month or more frequently) that is still uncontrolled by pumping or other treatments; 7. known severe allergic reactions to adebrelimab, apatinib, albumin paclitaxel active ingredients, and or any excipients; 8. Active, known, or suspected autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus rheumatoid arthritis, and inflammatory bowel disease. Type I diabetes mellitus (controlled by insulin therapy), residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, or expected not to recur in the absence of external irritation may be allowed; patients with eczema, psoriasis, lichen simplex chronicus, or dermatologic manifestations of vitiligo (psoriatic arthritis is excluded) who have rash covering less than 10% of body surface area, adequately controlled disease at baseline, and require only low-potency topical steroids may enter the study if the underlying disease has not worsened acutely in the past 12 months (psoralen plus ultraviolet radiation [PUVA], methotrexate, retinoids, biologics, oral calcineurin inhibitors, high-potency or oral steroids are not required); 9. Diagnosis of immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study. Physiological doses of corticosteroids (= 10 mg/day prednisone or equivalent) were permitted; 10. Subjects who have not recovered to CTCAE grade = 1 due to adverse events caused by previous treatment (except alopecia); other toxicities caused by previous anti-tumor treatment are expected to be unresolved and have long-term persistent sequelae, such as neurotoxicity caused by platinum-based treatment, are allowed to be enrolled; 11. Diagnosis of other malignancies within 5 years of the first dose, with exceptions including radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ; 12. Patients with symptomatic brain metastases (patients with stable brain metastases more than 2 weeks after radiotherapy can be enrolled); 13. History of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year before the first dose; 14. Uncontrolled active infection; 15. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 16. Cirrhosis, active hepatitis *; * active hepatitis - hepatitis B reference: HBsAg positive, more than the upper limit of normal (1000 copies/m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;disease control rate;duration of response;progression free survival;adverse event;serious adverse event;Tumor markers;Quality of life; | — |
Countries
China
Contacts
Public ContactLinlin Wang
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed