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Radiotherapy can activate local and systemic immune responses through a variety of mechanisms, which can enhance anti-tumor immune effects. The dose fractionation pattern of radiotherapy has an important influence on the occurrence of immune-induced effects. Stereotactic body radiation therapy (SBRT) has obvious advantages in activating interferon effects and inducing abscopal effects. SBRT combined with immunity can enhance the abscopal effect induced by radiotherapy and play a synergistic role. The 8Gy×3 fractionation scheme is currently the most widely used stereotactic radiotherapy scheme. Because we conducted this study, the primary lesion received large-fraction partial tumor irradiation and then received adebrelimab combined with chemotherapy induction treatment for 2 cycles, followed by sequential chest radiotherapy for the treatment of limited-stage small cell lung cancer, to explore the effectiveness and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | SERT+Chemo-immunotherapy+CCRT+Immunotherapy maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | Induction therapy:Adebrelimab, 1200mg, d1, q3w, 2 cycles; Maintenance therapy:Adebrelimab, 1200mg, d1, q3w, until disease progression or unbearable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progress Free Survival | 24months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 24months | |
| Overall survival | 24months | |
| TRAEs |
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Inclusion Criteria:
1. Age 18-70 years old; 2. Limited-stage small cell lung cancer (AJCC 8th) confirmed by histology or cytology; 3. Subjects have not received any treatment for SCLC; 4. Have measurable target lesions according to RECIST v1.1; 5. ECOG score of 0-1; 6. Life expectancy ≥ 12 weeks; 7. Normal function of major organs, that is, meet the following criteria:
Routine blood tests must meet the following criteria (no blood transfusion, no use of hematopoietic factors, and no use of drug correction within 14 days):
Biochemical tests must meet the following criteria:
Coagulation function must meet the following requirements: INR≤1.5×ULN and APTT≤1.5×ULN; 8. Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study medication, and the result must be negative, and they must be willing to use a medically approved high-efficiency contraceptive measure (such as intrauterine contraceptive device, contraceptive pills or condoms) during the study and within 3 months after the last administration of the study medication; for male subjects whose partners are female subjects of childbearing age, they must be surgically sterilized or agree to use an effective contraceptive method during the study and within 3 months after the last administration of the study medication.
9. The subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
Exclusion Criteria:
1 1. 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. Known to have allergic reactions, hypersensitivity reactions or intolerance to adebrelimab (SHR-1316), etoposide, cisplatin or its excipients; 14. Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks from the end of the previous clinical study (last medication) or 5 half-lives of the study drug; 15. Subjects with a history of psychotropic drug abuse, alcoholism or drug abuse; 16. The researcher believes that there are any conditions that may harm the subject or cause the subject to be unable to meet or perform the study requirements.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lujun Zhao, Professor | Contact | 13102258620 | zhaolujun@tjmuch.com |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| EC/EP | Drug | Chemotherapy: standard chemotherapy EC/EP |
|
| SBRT | Radiation | 8Gy*3 |
|
| Chest radiotherapy | Radiation | Chest radiotherapy: conventional fractionation mode 2Gy QD total dose 60Gy or 1.5Gy BID total dose 45Gy, according to the patient's physical condition, concurrent EP or EC chemotherapy can be considered |
|
| 24months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |