Non-small Cell Lung Cancer
Conditions
Interventions
Cryoablation combined with PD-1 inhibitor therapy group:NA
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Sign an informed consent form; 2.Age >= 18 years; 3.Histologically or cytologically diagnosed with NSCLC; 4.Imaging shows locally advanced or metastatic disease (Stage III B, III C, or IV) (AJCC 8th edition); 5.Negative for driver genes such as EGFR and ALK; 6.Previously received first-line PD-(L)1 inhibitor +/- chemotherapy with secondary resistance resulting in slow/oligoresponsive progression; 7.Evaluated by a radiologist and investigator as having resectable lesions; 8.According to RECIST 1.1 criteria, at least one measurable lesion excluding resectable lesions; 9.ECOG PS 0-1; 10.Expected survival >= 3 months; 11.Sufficient organ function: a) Hematological: ANC >=1.5×10^9/L, PLT >=70×10^9/L, HGB >=90 g/L. b) Hepatic: TBIL =28 g/L; ALP =1 week and investigator-confirmed. c) Renal: Serum Cr =50 mL/min (Cockcroft-Gault formula). d) Coagulation: INR <=1.5, PT <=1.5×ULN, aPTT <=1.5×ULN. Exception: For anticoagulated patients, PT/INR within therapeutic range of anticoagulant is acceptable. 12.Provide sufficient tissue specimens or blood specimens to test for subsequent analysis; 13.If female of childbearing potential, be willing to use an adequate method of contraception and have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
Exclusion criteria
Exclusion criteria: 1.Mixed histology of small cell and non-small cell lung cancer. 2.Primary immunotherapy resistance. 3.Driver gene-positive status. 4.Contraindications to cryoablation therapy. 5.Current participation in interventional clinical trials or receipt of other investigational drugs/devices within 4 weeks prior to first dose. 6.Systemic treatment with Chinese herbal medicine or immunomodulators (e.g., thymosin, interferon, interleukin) for antitumor purposes within 2 weeks before first dose (excluding localized use for pleural effusion control). 7.Palliative radiotherapy within 7 days before first dose. Exception: Patients receiving palliative radiotherapy >7 days prior may enroll if: No residual radiotherapy-related toxicities; No corticosteroid requirement; Absence of radiation pneumonitis; No lung radiotherapy (>30 Gy) within 6 months. 8.Live attenuated vaccines administered within 4 weeks before first dose (or planned during the study). Note: Inactivated vaccines (e.g., seasonal influenza) are permitted; live attenuated influenza vaccines are prohibited. 9.Current systemic immunosuppressive therapy within 7 days before first dose (excluding topical/nasal corticosteroids or physiological systemic doses =3 days are permitted). 14.Uncontrolled systemic diseases, including: Active infections; Congestive heart failure (NYHA class >=II); Severe arrhythmias requiring medication; Hepatic/renal/metabolic disorders; Type I/II respiratory failure; Tumor compression of critical organs (e.g., esophagus, SVC invasion); Gastrointestinal perforation/fistula, bowel obstruction, extensive bowel resection, Crohn’s disease, ulcerative colitis, or chronic diarrhea within 6 months. 15.Prior solid organ or hematopoietic stem cell transplantation (excluding corneal transplants). 16.HIV infection (HIV 1/2 antibody-positive) or active syphilis. 17.Active tuberculosis requiring medical intervention (e.g., pulmonary TB). 18.Untreated active hepatitis B: Eligible if: HBsAg(+) or HBcAb(+) with HBV DNA =3 hypersensitivity to sintilimab or its excipients. 22.Pregnancy, lactation, or intention to conceive during the study. 23.Refusal to use highly effective contraception during treatment and for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ARR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate;ACR;Severity of adverse events;PFS; | — |
Countries
China
Contacts
Public ContactCheng Yuan
Peking University First Hospital
Outcome results
None listed