Efficacy and Safety of a Therapy Combining Sintilimab and Chemotherapy With Cryoablation in the First-Line Treatment of Advanced Nonsquamous Non–Small Cell Lung Cancer: Protocol for a Phase II, Pilot, Single-Arm, Single-Center Study

• DOI: 10.2196/64950
• Publication Date: 2024-09-28T13:30:03Z
• Authors: Zhiqiang Gao; Jiajun Teng; Rong Qiao; Jialin Qian; Feng Pan; Meili Ma; Jun Lu; Bo Zhang; Tianqing Chu; Hua Zhong
• Keywords: Cryoablation

Background Immunotherapy has significantly advanced lung cancer treatment, particularly in nonsquamous non–small cell (NSCLC), with overall response rates between 50% and 60%. However, about 30% of patients only achieve a stable disease state. Cryoablation shown potential to enhance immunotherapy by modifying the tumor’s immune microenvironment through release antigens factors. Addressing how boost these is critical. Objective This study aims investigate efficacy safety immunochemotherapy combination cryoablation as first-line treatment for NSCLC. Methods phase II, pilot, open-label, single arm, center, interventional study. Patients stage IIIB IIIC or IV NSCLC T staging ranging from T1 T2b will receive sintilimab (200 mg/m2 every 3 weeks) chemotherapy. After 2 cycles, feasibility be considered those multidisciplinary team. freeze-thaw cycles performed main lesion. The third cycle systemic therapy begin 7 (SD 3) days after cryoablation. A total 20 enrolled. Treatment continue until progresses, there unacceptable toxicity, participant withdraws consent, other discontinuation criteria are met, reaches completion. primary objective assess progression-free survival (PFS). secondary duration response, control rate, (OS), profile. exploratory compare factor changes at 1, 3, Survival time estimated using Kaplan-Meier method calculate median PFS OS. Any adverse events that occur during trial promptly recorded. Results project was funded 2024, enrollment completed 2025. first results expected submitted publication 2027. Conclusions provide evidence Although it limited sample size, findings this used future inform design fully powered, 2-arm, larger-scale Trial Registration ClinicalTrials.gov NCT06483009; https://clinicaltrials.gov/study/NCT06483009 International Registered Report Identifier (IRRID) PRR1-10.2196/64950