To compare the efficiency between surgery and radiotherapy after SHR-1316 (Adebrelimab)and platinum-containing doublet induction therapy for limited-stage small cell lung cancer
after signing informed consent;
Aged 18-70;
Histologically or cytologically confirmed SCLC, imaging examination and other confirmed limited-stage small cell lung cancer, and without previous treatment;
For clinical stage IIB-III, all patients should have clear lymph node pathology by EBUS to exclud occult lymph node metastasis.
Received any systemic anticancer therapy, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental therapy;
Patients with other malignancies within five years prior to the start of the trial;
Combined with unstable systemic diseases, such as uncontrolled hypertension, severe arrhythmia, etc;
With active, known or suspected autoimmune disease, or autoimmune paraneoplastic syndrome requiring systemic therapy;
Parallel
chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy
Combination productInduction treatment stage: SHR-1316(Adebrelimab)，20mg/kg,+Cisplatin 75mg/m2, d1+ etoposide 100mg/m2, d1,d2,d3, q3w, iv, 4 cycles. Patients who are able to receive surgery after assessed by two surgons would receive surgery or radiotherapy randomly. Adjuvant/ maintenance treatment stage: SHR-1316，20mg/kg, iv, q3w,up to 1 year
progression-free survival
It refers to the time from the first administration of SHR1316 in this study to the disease progression or death (including any cause of death in the case of no progression) , regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
incidence of adverse events
The frequency of severe adverse events as assessed by CTCAE 5.0 from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
pathological response
To evaluate the pathological response rate (major pathological response and complete pathological response) of the surgical population after neoadjuvant therapy with SHR-1316 and chemotherapy for operable LD-SCLC according to the evaluation criteria of pathological response after neoadjuvant therapy recommended by the International Association for the Study of Lung Cancer (IASLC)
objective response rate
It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation
overall survival
It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
biological predicted markers
to explore potential predictive biomarkers in archived and/or fresh tumor tissue and/or blood (or blood derivatives), including but not limited to programmed cell death protein ligand 1 (PD-L1) expression as determined by immunohistochemistry (IHC), gene expression profile (GEP), tumor mutational burden (TMB), tumor-infiltrating immune cell changes, etc., to evaluate the association of these markers with the study of treatment response or resistance mechanisms
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Shanghai Pulmonary Hospital, Shanghai, China
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
