About this trial
After the treatment of advanced non-small cell lung cancer with immune checkpoint inhibitor PD-1/PD-L1 monoclonal antibody, if the treatment response of complete response (CR) or partial response (PR) can be achieved in the early stage, the patients are expected to obtain a better long-term survival rate. Radiotherapy can synergistically improve the effect of immunotherapy. Therefore, we propose a hypothesis: in patients with advanced lung cancer, if only stable disease (SD) is achieved after PD-1 antibody immunotherapy in the early stage, by increasing the stereotactic radiotherapy (SBRT) for primary or metastatic lesions, in order to improve the mechanism of tumor antigen release, promote the activation and activation of effector T cells, and increase the sensitivity of immunotherapy, so as to achieve the goal of early improvement of objective remission rate (ORR). It is expected to improve the long-term survival rate of patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol;
Patients with stage IIIB, IIIC and stage IV NSCLC (according to the definition of the 8th edition of the American Joint Commission on cancer), who have not been treated and cannot receive radical surgery or radiotherapy confirmed by histopathology, received 3-4 cycles of PD1 antibody ± chemotherapy in the early stage, and the efficacy was evaluated as SD;
Previously, no EGFR sensitive mutation and ALK, ROS1 gene fusion mutation were detected based on tissue examination;
There are measurable lesions evaluated by researchers according to RECIST version 1.1;
Disqualifiers
The patient's compliance is poor and violates the test regulations;
Patients with positive driver gene are known to carry EGFR mutation or ALK, ROS1 gene translocation;
There are dysfunction of important organs of liver and kidney, such as myocardial infarction, angina pectoris, liver transaminase significantly increased;
Serious adverse drug reactions occurred during induction;
Trial population
Patients with stage IIIB, IIIC and stage IV NSCLC (according to the definition of the 8th edition of the American Joint Commission on cancer), who have not been treated and cannot receive radical surgery or radiotherapy confirmed by histopathology, received 3-4 cycles of PD1 antibody ± chemotherapy in the early stage, and the efficacy was evaluated as stable disease
Trial design
Cohort
Prospective
Treatments tested in this trial
PD-1 inhibitor
DrugAfter receiving PD-1 inhibitor treatment in the first three cycles, patients with locally advanced or advanced NSCLC whose curative effect is evaluated as stable disease receive SBRT combined with PD-1 inhibitor treatment
Treatment groups
Trial outcomes
Primary outcomes
objective response rate (ORR)
The proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including cases of complete response and partial response.
Sponsors and contacts
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