Non-small Cell Lung Cancer
Conditions
Keywords
Cryoablation, Serplulimab, Early non-small cell lung cancer
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.
Interventions
PROCEDURECryoablation
Patients undergo cryoablation.
DRUGSerplulimab
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.
Sponsors
Shanghai Henlius Biotech Co., Ltd.
AccuTarget MediPharma (Shanghai) Co., Ltd
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactJiayuan Sun
Outcome results
None listed