Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung Cancer

Not Applicable

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT06580665
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate tumour cells for patients ineligible for surgery. It has been reported that cryoablation may enhance immune response and synergize with immunotherapy.

This study is a multicenter, randomized, controlled, exploratory trial, and is expected to enroll a total of 134 patients. The enrolled patients were stage Ia, Ib, or IIa lung cancer with negative driver gene mutations, who are considered high-risk for surgery or refuse surgery based on multidisciplinary evaluation. Eligible patients will be randomly assigned in a 1:1 ratio to receive either cryoablation alone (CA group) or cryoablation combined with immunotherapy (I-CA group). The study aims to evaluate the safety and clinical benefits of combining immunotherapy with cryoablation in the treatment of early-stage NSCLC by comparing progression-free survival (PFS), objective response rate (ORR), overall survival (OS), and the incidence of adverse events between the two groups.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-29
• Last Update Submitted: 2024-08-29
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30
• Study Start: 2024-09-01
• Primary Completion: 2028-09-01
• Study Completion: 2030-08-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1. Pathologically diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested stage Ia, Ib, or IIa (size≤5 cm, T1-T2N0M0), according to the 9th edition of the TNM classification for lung cancer;
2. Negative driver gene mutation: driver genes were defined as EGFR, ALK, etc;
3. Age ≥18 years old;
4. The ECOG PS score is 0-2;
5. Expected survival ≥3 months;
6. Patients who are considered high-risk for surgery/radiotherapy or refuse surgery/radiotherapy based on multidisciplinary evaluation;
7. Patients who have not received previous immunotherapy with PD-1, PD-L1 or CTLA-4 antibodies;
8. All patients must agree to receive cryoablation (with or without Serplulimab) as an initial therapy and sign a study-specific consent form.

Exclusion Criteria

1. Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
2. Patients whose chest CT indicated that the lung lesions could not be reached percutaneously or transbronchially;
3. Severe liver and kidney function and coagulation function abnormalities, platelet count <70×109/L;
4. Patients who have received other anti-tumor drugs in the past 6 months or have used immune checkpoint inhibitors before;
5. The patient has an uncontrolled disease (including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, etc.);
6. Primary immune deficiency or autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.);
7. Pregnant and lactating women;
8. Long-term use of steroid;
9. Other circumstances considered inappropriate for participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
3-year progression-free survival (PFS)	3 years	This refers to the length of time between the participant's first onset of disease progression or death from any cause after treatment.

Secondary Outcome Measures

Name	Time	Method
1-year, 2-year, and 3-year Objective Response Rate (ORR)	3 years	The percentage of patients that achieve complete response (CR) and partial response (PR) after treatment.
Overall Survival (OS)	5 years	The time from the start of treatment to the patient's death or the last follow-up, with a maximum observation period of 5 years from randomization.
Incidence of Adverse Events	1 year	Adverse events include those related to the cryoablation procedure occurring during or after the procedure, as well as drug-related adverse events caused by immunotherapy.
Potential Predictive and Immunological Biomarkers (lymphocyte phenotypes, PD-L1 expression, cytokines)	1 year	This refers to the changes from baseline in the immunological responses following the cryoablation (with or without Serplulimab) and comparison between the two groups, including the percentage and function of lymphocyte phenotypes, the expression of PD-L1, the concentration of IFN-γ levels, etc.