Clinical trial NCT06580665: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: Cryoablation
Serplulimab
Early non-small cell lung cancer
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Henlius Biotech Co., Ltd.
name: AccuTarget MediPharma (Shanghai) Co., Ltd
First posted: 2024-08-30
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 \&lt;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.

Primary outcomes:
measure: 3-year progression-free survival (PFS)
timeFrame: 3 years
Secondary outcomes:
measure: 1-year, 2-year, and 3-year Objective Response Rate (ORR)
timeFrame: 3 years
measure: Overall Survival (OS)
timeFrame: 5 years
measure: Incidence of Adverse Events
timeFrame: 1 year
measure: Potential Predictive and Immunological Biomarkers (lymphocyte phenotypes, PD-L1 expression, cytokines)
timeFrame: 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: