SCLC
Conditions
Interventions
LDRT+AK104+chemotherapy:During the induction therapy period, subjects received the following regimen: LDRT 15Gy/5f (C1D1-C1D5)+Cardonizumab (selected dose level, D1)+Platinum (cisplatin, carboplatin,
Patients who achieve complete response (CR) or partial response (PR) receive maintenance therapy with the following regimen: LDRT 15Gy/5f (C1D1-C1D5) for primary/mediastinal positive lymph nodes/metas
Sponsors
West China Hospital,Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form; 2. Male or female aged >=18 years and =3 months; 10. Adequate hematologic and end-organ function, as defined by the following laboratory test results, which must be obtained within 14 days prior to the first dose of study treatment: Absolute neutrophil count (ANC) >=1.5 ×10^9/L (1500/µL) (without treatment with hypergranulocyte colony-stimulating factor); Lymphocyte count >=0.5×10^9/L (500/µL); Platelet count >=100×10^9/L (100000/µL) (in the case of blood transfusion); Hemoglobin >=90g/L (9.0g/dL); - Patients can be given blood transfusion therapy to meet this criterion; Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =60mL/min (calculated by Cockcroft-Gault formula); albumin >=25g/L (2.5g/dL); For patients not receiving anticoagulant therapy: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) =12 months, and
Exclusion criteria
Exclusion criteria: 1. Symptomatic, untreated, or active progressive central nervous system (CNS) metastases; 2. History of leptomeningeal disease; 3. Poorly controlled tumor-related pain; 4. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently); 5. Poorly controlled or symptomatic hypercalcemia (ionized calcium > 1.5mmol/L, calcium >12mg/dL or corrected calcium >ULN); 6. Has an active or history of autoimmune disease or immunodeficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 5 for a more comprehensive list of autoimmune diseases and immunodeficiencies), with the following exceptions: Patients with a history of autoimmune hypothyroidism who are receiving thyroid replacement therapy are eligible for this study; Patients with type I diabetes mellitus treated with insulin regimen and blood sugar control are eligible for this study; Patients with eczema, psoriasis, chronic lichen simplex, or vitiligo with only skin symptoms (e.g.: excluding patients with psoriatic arthritis) are eligible for this study if all of the following conditions are met: The rash must cover ). 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; 12. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia, severe pneumonitis, or any active infection that may affect the safety of the patient; 13. Active infection with systemic anti-infective therapy within two weeks prior to the first dose (excluding antiviral therapy for hepatitis B or hepatitis C); 14. Previous allogeneic stem cell or solid organ transplantation; 15. Presence of any other disease that contraindicates the use of investigational drugs, may affect the interpretation of results or treatment complications may pose a high risk to the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event;6-month Progressives Free Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Disease Control Rate;Progressives Free Survival;Overall Survival;6-month Progressives Free Survival rate;12-month Progressives Free Survival rate;12-month Overall Survival rate; | — |
Countries
China
Contacts
Public ContactYou Lu
West China Hospital,Sichuan University
Outcome results
None listed