RecruitingPhase 2NCT06127303

Toripalimab Combined With Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC

A Single-arm, Phase II Clinical Study of Toripalimab Combined With Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC


Sponsor

Shanghai Chest Hospital

Enrollment

54 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Immunotherapy with programmed death-1(PD-1) inhibitors is now standard therapy for first-line use in patients with driver-negative advanced NSCLC, whether as single-agent or in combination with chemotherapy. After progression of first-line immunotherapy, NSCLC patients may be treated with chemotherapy, radiotherapy or targeted therapies, among others. Recently, Immune Checkpoint inhibitors (ICIs) rechallenge has become a highly anticipated option. Although the objective response rate of the ICIs rechallenge patients has decreased substantially compared with the efficacy of the first ICI treatment, nearly 50% of patients can regain disease control. Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate viable tumour cells in target tissues. It has been reported that ablation can enhance immune response. The objective of this study was to evaluate the efficacy and safety of toripalimab (PD-1) in combination with cryoablation in the treatment of oligometastatic driver-negative advanced NSCLC after first-line immunotherapy progress.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of Toripalimab (an immunotherapy drug) and cryoablation (freezing tumors to destroy them) as a first-line treatment for people with advanced non-small cell lung cancer (NSCLC) whose cancer has begun to progress in a limited number of spots (called oligoprogression) after initial treatment. **You may be eligible if:** - You are 18–75 years old with confirmed stage IV non-small cell lung cancer - Your cancer has no driver gene mutations (EGFR, ALK, ROS1, etc.) - Your cancer has shown oligoprogression (1–5 metastatic spots in no more than 3 organs) after first-line therapy - You have good physical functioning (ECOG score 0–1) - You have at least one measurable tumor **You may NOT be eligible if:** - Your cancer has spread to the brain (active brain metastases) - You have a history of autoimmune disease requiring systemic immunosuppression - You have active liver disease, hepatitis, cirrhosis, or active tuberculosis - You are HIV positive - You have previously received targeted therapies for NSCLC - You are pregnant or received a live virus vaccine within 30 days of starting treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab

Toripalimab treatment (240mg intravenously every 3 weeks) started on day 3 after cryoablation, until occurrence of termination event specified in the protocol.

OTHERCryoablation

The ablation was performed on the first day of each cycle, and the target lesions were comprehensively screened for cryoablation based on the location and size of the lesions.


Locations(3)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Zhongshan Hospital, Fudan University

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT06127303


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