SLC
Conditions
Interventions
Test group:Adbelimab + Apatinib mesylate + albumin bound paclitaxel
Sponsors
HenanCancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent; 2. Age =18 years old; 3. ECOG score 0~1; 4. Predicted survival =12 weeks; 5. Recurrent small cell lung cancer confirmed by histopathology or cytology; 6. Patients who progress after first-line immunotherapy; 7. Have at least one measurable lesion (according to RECIST 1.1 criteria); 8. The main organs function normally and meet the following standards: (1) The standard of blood routine examination shall be met (no blood transfusion or blood products within 14 days, no correction by G-CSF and other hematopoietic stimulating factors) : A. Hemoglobin (Hb) = 90 g/L; B. neutrophil number (ANC) = 1.5 × 109/L; C. Platelet count (PLT) = 100 ×109/L; (2) Biochemical examination shall meet the following standards: A. Total bilirubin (TBIL) 60ml/min (Cockcroft-Gault formula); D. Routine urine test results showed urine protein (UPRO) 1.5 ×ULN without clinical or imaging evidence of pancreatitis could be included in the group); Amylase =1.5 × ULN (patients with amylase >1.5 × ULN without clinical or imaging evidence of pancreatitis could be enrolled in the group); alkaline phosphatase (ALP) is less than 2.5ULN. 9. Women of reproductive age should agree to use effective contraception during the study period and for six months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should agree to use contraception during the study period and for six months after the study period ends;
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions were excluded from the study: 1. Allergic to therapeutic drugs; 2. Anti-vascular endothelial growth factor (VEGF) or vascular endothelial cell growth factor receptor (VEGFR) therapy with Apatinib, anrotinib, bevacizumab, sorafenib etc.; Have used yew drugs in the past; 3. Patients with hemoptysis (>5ml fresh blood within 4 weeks) or potential high-risk hemoptysis judged by researchers; 4. Subjects with clinical symptoms/untreated central nervous system metastases (e.g. brain, spinal cord), pia metastases; Subjects with active or new untreated CNS metastases found on imaging during the screening period were excluded. (unless asymptomatic, or stable after treatment, no imaging evidence of new BMS or extended BMS was found at least 2 weeks after completion of BMS treatment to allow inclusion); 5. Patients whose imaging shows that the tumor has invaded important blood vessels or whose tumor is judged by the investigator to be highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study; 6. Active autoimmune disease or immunodeficiency, or a medical history of the following, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitaritis, vasculitis, nephritis, etc.) shall not be included. Exceptions include: Patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy. Patients with type 1 diabetes whose blood sugar is under control after treatment with an insulin administration regimen may participate in this study. 7. Patients receiving systemic treatment with excessive doses of antibiotics within the past 2 weeks; 8. Patients with arteriovenous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis and pulmonary embolism within 6 months before the first administration; 9. Gastrointestinal diseases or conditions that the investigator determines may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable gastrointestinal tumors, or other conditions that the investigator determines may cause gastrointestinal bleeding or perforation, People with multiple factors affecting oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhoea and intestinal obstruction); 10. Hypertension that cannot be controlled stably by drugs is prescribed as: systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg; 11. Surgical procedures (excluding biopsy) were performed within 28 days prior to inclusion in this study or surgical incisions were not completely healed; 12. Have received or plan to receive live attenuated vaccine within 4 weeks prior to initial administration; 13. Receiving any other experimental drug treatment or participating in other intervention studies within 4 weeks prior to signing the informed consent; 14. Within 5 years, subjects have had or co-developed other malignancies requiring active treatment (except those with sufficient treatment, such as basal cell or squamous cell skin cancer, cervical carcinoma in situ, and breast cancer in situ); 15. Cardiovascular disease of significant clinical significance, including but not limited to acute myocardial infarction, severe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;progression-free survival. PFS;Overall survival, OS;Six-month survival rates;Duration of drug treatment; | — |
Countries
china
Contacts
Public ContactHongbo Wu
Henan Cancer Hospital
Outcome results
None listed