Abstract 722TiP
Background
Immunotherapy has significantly advanced lung cancer treatment, particularly in non-squamous non-small cell lung cancer (NSCLC), with response rates between 50%-60%. However, about 30% of patients only achieve stable disease. Cryoablation has shown potential to enhance immunotherapy by modifying the tumor's immune microenvironment through the release of antigens and immune factors. Addressing how to boost the immune response in these patients is critical. Therefore, this study aims to investigate the efficacy and safety of immuno-chemotherapy in combination of cryoablation as the first-line treatment of advanced NSCLC.
Trial design
This is an ongoing, phase II, pilot, open-label, single arm, single center, interventional study. Patients with stage IIIB-IIIC or IV NSCLC with T staging ranging from T1 to T2b will receive sintilimab (200mg/ m2, ivgtt, q3w) and chemotherapy. After two cycles, the feasibility of cryoablation is considered for those with stable disease by multidisciplinary team. Cryoablation with three freezing-thawing cycles will be performed for main lesion. The third cycle of systemic therapy begins 7±3 days after cryoablation. A total of 20 patients will be enrolled. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, other discontinuation criterion is met, or study completion. The primary objective is to assess Progression-Free Survival (PFS). The secondary objective is to assess the efficacy through, Duration of Response (DoR), Disease Control Rate (DCR), Overall Survival (OS) and safety profile. The primary and secondary efficacy endpoints of this study are 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. The exploratory objective is to investigate the immune factor change after two cycles of immune-chemotherapy, and at 1, 3, and 7 days after cryoablation.
Clinical trial identification
NCT06483009.
Legal entity responsible for the study
The authors.
Funding
Boston Scientific, Innovent Biologics.
Disclosure
All authors have declared no conflicts of interest.