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

Official title

Randomized Clinical Trials Comparing Immunotherapy Plus Cryoablation (I-CA) Versus Cryoablation Alone for Stage I, Selected Stage IIa, Non-Small Cell Lung Cancer

Overview

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.

Interventions

• Procedure Cryoablation
  Patients undergo cryoablation.
• Drug Serplulimab
  Patients undergo cryoablation. If there are no significant postoperative complications, Serplulimab should be administered immediately. Cycles with Serplulimab repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Primary outcome measures

• 3-year progression-free survival (PFS) [Time frame: 3 years]

Secondary outcome measures (4)

• 1-year, 2-year, and 3-year Objective Response Rate (ORR) [Time frame: 3 years]
• Overall Survival (OS) [Time frame: 5 years]
• Incidence of Adverse Events [Time frame: 1 year]
• Potential Predictive and Immunological Biomarkers (lymphocyte phenotypes, PD-L1 expression, cytokines) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

• 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;
• Negative driver gene mutation: driver genes were defined as EGFR, ALK, etc;
• Age ≥18 years old;
• The ECOG PS score is 0-2;
• Expected survival ≥3 months;
• Patients who are considered high-risk for surgery/radiotherapy or refuse surgery/radiotherapy based on multidisciplinary evaluation;
• Patients who have not received previous immunotherapy with PD-1, PD-L1 or CTLA-4 antibodies;
• All patients must agree to receive cryoablation (with or without Serplulimab) as an initial therapy and sign a study-specific consent form.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 5 centers

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
• The First Affiliated Hospital of Nanchang University — Nanchang
• Shanghai Chest Hospital — Shanghai
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT06580665 · IS24040

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗