NCT06483009

Efficacy and Safety of Combination Therapy of Sintilimab and Chemotherapy With Cryoablation in NSCLC

Efficacy and Safety of Combination Therapy of Sintilimab and Chemotherapy With Cryoablation in the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the efficacy and safety of immuno-chemotherapy in combination of cryoablation as the first-line treatment of advanced NSCLC

Conditions

• Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DEVICE	Cryoablation	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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2024-07-01
• Last updated: 2024-08-30

Regulatory

• FDA-regulated device study