Status:
NOT_YET_RECRUITING
Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung Cancer
Lead Sponsor:
Shanghai Chest Hospital
Collaborating Sponsors:
Shanghai Henlius Biotech Co., Ltd.
AccuTarget MediPharma (Shanghai) Co., Ltd
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 immu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 11 2030
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06580665
Start Date
September 1 2024
End Date
August 11 2030
Last Update
August 30 2024
Active Locations (5)
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1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
2
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
3
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
4
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China