This study aims to investigate the efficacy and safety of immuno-chemotherapy in combination of cryoablation as the first-line treatment of advanced NSCLC
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Cryoablation: For subjects assessed as stable disease (SD) after two cycles of medication, one session is performed under local anesthesia after assessment. The multidisciplinary team, including investigators and radiologists, evaluates the feasibility of tumor ablation based on the size, location, and proximity to major blood vessels. Criteria for eligible lesions include a maximum diameter \<5cm, relatively isolated lesion location, and not adjacent to major blood vessels or vital structures. Cryoablation is performed using a 17G IceRod Plus 1.5 cryoablation needle, guided by CT, and avoiding nearby anatomical structures using the Visual-ICE cryoablation system.
Progression-free survival (PFS)
Assessed by the investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST. In case of any discrepancies, the investigators will consult a third party.
Time frame: up to 3 years
Objective response rate (ORR)
Proportion of subjects whose tumors were assessed by the investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST. In case of any discrepancies, the investigators will consult a third party.
Time frame: up to 3 years
Disease control rate (DCR)
Proportion of subjects whose tumors were assessed as CR, PR or stable disease (SD) by the investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST. In case of any discrepancies, the investigators will consult a third party.
Time frame: up to 3 year
Duration of response (DOR)
The time from onset of response to progression or death due to any reason, whichever occurs earlier
Time frame: up to 3 years
Safety profile
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: up to 3 years
Zhiqiang Gao, MD
CONTACT
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