Limited-stage small cell lung cancer
Conditions
Interventions
Experimental group:Low-dose radiotherapy (LDRT) combined with adebelimab and chemotherapy
Sponsors
Hunan Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Patients diagnosed by histological or cytological methods and judged by the investigator to be eligible for curative R0 surgical resection of limited-stage small cell lung cancer (stage II A - III A) with cancer confined to one lung and positive N1 or N2 lymph nodes (refer to the 2025 CSCO guidelines for staging); 3. The subjects have not received any systemic treatment; 4. At least one measurable lesion that meets the RECIST v1.1 criteria (see Appendix 1) is present; 5. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1 (ECOGPS scoring criteria are provided in Appendix 3); 6. The expected survival period is >= 12 weeks; 7. Normal major organ functions, that is, meeting the following criteria: (1) Blood routine examination must meet (within 14 days without blood transfusion, without the use of hematopoietic factors and without the use of drugs to correct): a. ANC >= 1.5×10^9/L; b. PLT >= 100×10^9/L; c. HB >= 90 g/L; (2) Biochemical examination must meet the following standards: a. TBIL = 50 mL/min (Cockcroft-Gault formula); d. Coagulation function must meet: INR = 50%; 8. The subjects are willing to undergo surgery and have good pulmonary function to tolerate surgical treatment, a. Maximum vital capacity VC% > 60%; b. Maximum one-second forced expiratory volume FEV1 > 1.2L; c. One-second rate (FEV1/FVC) FEV1% > 40%; d. Postoperative predicted value FEV1 (ppoFEV1) > 40%; e. Postoperative predicted value carbon monoxide diffusion capacity DLCO (ppoDLCO) > 60%; 9. Female subjects of childbearing age must undergo a serum pregnancy test 3 days before starting the study medication, and the result must be negative, and are willing to use a medically approved highly effective contraceptive method (such as: intrauterine device, contraceptive pills or condoms) during the study period and within 3 months after the last administration of the study medication; for male subjects whose partners are of childbearing age, surgical sterilization must be performed, or they must agree to use an effective method of contraception during the study period and within 3 months after the last administration of the study medication. 10. The subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
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 t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival period;Surgical R0 resection rate;Surgical safety indicators;Objective response rate;Major Pathological response;Safety;Recurrence free survival;Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactYang Desong;Liu Huai
Hunan Provincial Cancer Hospital
Outcome results
None listed