To hear about similar clinical trials, please enter your email below
Trial Title:
Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung Cancer
NCT ID:
NCT06580665
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Cryoablation
Serplulimab
Early non-small cell lung cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Cryoablation
Description:
Patients undergo cryoablation.
Arm group label:
Cryoablation alone (CA group)
Arm group label:
Cryoablation combined with immunotherapy (I-CA group)
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
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.
Arm group label:
Cryoablation combined with immunotherapy (I-CA group)
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.
Criteria for 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 <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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xinjiang Medical University
Address:
City:
Ürümqi
Country:
China
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Start date:
September 1, 2024
Completion date:
August 11, 2030
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Henlius Biotech Co., Ltd.
Agency class:
Other
Collaborator:
Agency:
AccuTarget MediPharma (Shanghai) Co., Ltd
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06580665
