IIIb - IV stage of drive genes negative non-small cell lung cancer
Conditions
Interventions
Combination therapy group:PD1 monoclonal antibody: intravenous injection of PD-1 monoclonal antibody (3mg/kg) was performed for the first time, followed by cryoablation two weeks later, and intravenou
Combination therapy group:Cryoablation: CT-guided percutaneous lung puncture cryoablation was performed 2 weeks after the first PD1 monoab administration. The cryotherapy lasted for 15 minutes every c
Control group:PD1 monoclonal antibody: PD-1 monoclonal antibody is given intravenously at a rate of 3mg/kg every 3 weeks, followed by administration once every 3 weeks.
Sponsors
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Pathology and molecular classification confirmed IIIb ~ IV stage of drive gene negative (EGFR/ALK ROS1) in patients with non-small cell lung cancer; (2) Progression or intolerance after previous first-line chemotherapy containing platinum, but no PD1/PD-L1 immunocheckpoint inhibitor treatment; (3) Measurable lesions >= 2cm in the lung were confirmed by CT, and feasible puncture ablation was evaluated; (4) ECOG 6 months; (5) Age > 18 years old, = 1.5 x 10^9/L · Platelets >= 70 x 10^9/L · Hemoglobin >= 9.0 g/dL · Serum aspartic aminase (AST) and alanine aminotransferase (ALT) 3.5g/dL · Total bilirubin < 2mg/dL (7) Sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Diffuse lesions in both lungs cannot be improved by ablation; (2) Extensive pleural metastasis with massive pleural effusion; (3) Brain metastasis; (4) Severely impaired lung function, with maximum gas volume < 40%; (5) Platelet count < 70 x 10^9/L and severe coagulation dysfunction cannot withstand surgery (anticoagulant therapy and/or anticoagulant drug users should stop using for more than 1 week before ablation therapy); (6) Poor systemic condition (multiple systemic metastases, severe infection, high fever), obvious cachexia, severe dysfunction of important organs, severe anemia, and nutritional metabolism disorder cannot be improved in the short term; (7) Pregnant or lactating women; (8) Those who are not considered suitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactJianxin Qian
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed