Limited-stage small cell lung cancer
Conditions
Interventions
Experimental Group (Low-dose radiotherapy (LDRT) combined with adebelimab and chemotherapy as neoadjuvant therapy):Low-dose radiotherapy (LDRT) : 15 Gy/5: carried out from day 1 to day 5
The total dose of LDRT treatment is 15 Gy, given in 5 doses (3 Gy each time). LDRT should be scheduled before the administration of immunotherapy and chemotherapy
Preoperative neoadjuvant therapy
Adbe
EC regimen: 1) Etoposide Injection (E) : Continuous administration on days 1, 2, and 3, 100mg/m2, ivgtt, 21 days per cycle. 2) Carboplatin Injection (C) : Administered on the first day, AUC=5, by intr
Each treatment cycle lasts for 21 days, with 2 cycles
Medication duration: Two cycles of neoadjuvant therapy before the operation, and radiotherapy is only used before the first cycle of chemotherapy.
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. Patients with histologically or cytologically confirmed stage ?A-?A small-cell lung cancer (cancer confined to N1 or N2-positive lymph nodes in one lung) who are considered by the investigator to be amenable to curative R0 surgery (according to the 2025 CSCO guidelines); 3. The subjects had not received any systemic treatment; At least one measurable lesion meeting RECIST v1.1 criteria (see Appendix 1); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 3 for ECOGPS scoring criteria); 6. Expected survival time >=12 weeks; 7. Normal major organ function, i.e. meeting the following criteria: (1) Blood routine examination must meet (no blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days) : 1) ANC >=1.5×10^9/L; 2) platelet count >= 100×10^9/L; 3) HB >= 90 g/L; (2) Biochemical tests must meet the following criteria: 1) TBIL =50mL/min (Cockcroft-Gault formula); 4) Coagulation function: INR=50% 8. The subject is willing to undergo surgery and has good pulmonary function to tolerate surgical treatment. (1) VC% of maximal vital capacity >60% (2) FEV1>1.2L (3) FEV1/FVC FEV1%>40% (4) Postoperative predicted FEV1 (ppoFEV1) >40% (5) Postoperative predicted carbon monoxide diffusion capacity DLCO (ppoDLCO) 1>60%; 9. Female participants of childbearing age must have taken a serum pregnancy test with a negative result within 3 days before starting study medication and be willing to use a medically approved, highly effective contraceptive device (e.g., IUD, contraceptive pill, or condom) during the study and for 3 months after last administration of study medication; Male subjects whose partner is a female of reproductive age should be surgically sterilized or agree to use an effective method of contraception for the duration of the study and for 3 months after the last study dose. 10. The subjects voluntarily participated in the study, signed the informed consent form, and the compliance was good.
Exclusion criteria
Exclusion criteria: 1. Has received any anti-tumor treatment in the past, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine anti-tumor treatment; 2. Those with any active autoimmune diseases or a history of autoimmune diseases (as follows, but not limited to: moderate interstitial pneumonia or above, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis; those with vitiligo or childhood asthma that has been completely relieved and no intervention is required in adulthood can be included; Patients who require medical intervention with bronchodilators cannot be included. 3. Patients with congenital or acquired immune deficits, such as those infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA = 2000 IU/mL), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method), or co-infection with hepatitis B and C, and patients with active pulmonary tuberculosis; 4. Immunosuppressive drugs have been used within 14 days prior to the first use of the study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10 mg/ day prednisone or its equivalent drugs); 5. Live attenuated vaccines should be administered within 4 weeks before the first dose or during the study period. 6. Have suffered from other malignant tumors within the past five years; 7. There is evidence indicating a past or current history of pulmonary fibrosis, interstitial pneumonia (grade II or above), pneumoconiosis, radiation pneumonia, drug-induced pneumonia, and severe impairment of lung function, etc. 8. Those with hypertension who have not achieved good control through antihypertensive drug treatment (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); Or grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >=450ms in men and >=470ms in women); According to the NYHA standard, patients with grade ? to ? cardiac failure, or those whose left ventricular ejection fraction (LVEF) is less than 50% as indicated by echocardiography; 9. Suffering from grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval >=450ms in men and >=470ms in women). According to the NYHA criteria, patients with grade III-IV heart failure, or those with left ventricular ejection fraction (LVEF) 38.5°C during the screening period/before the first administration; 11. A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12. Pregnant or lactating women; Patients with fertility who are unwilling or unable to take effective contraceptive measures; 13. It is known that allergic reactions, hypersensitivity reactions or intolerances may occur to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological response;Surgical R0 resection rate;Recurrence free survival;Progression-Free Survival;Overall?Survival;Objective response rate;Surgical safety indicators;Safety;Detection of biomarkers related to therapeutic effect; | — |
Countries
China
Contacts
Public ContactYang Desong/Liu Huai
Hunan Cancer Hospital
Outcome results
None listed