Neoadjuvant Immunotherapy, NSCLC, Chemo-free Therapy
Conditions
Brief summary
The neoadjuvant strategy of immunotherapy combined with chemotherapy has been recommended for resectable or potentially resectable tumors without driver-gene alterations.However, the AE of chemotherapy is more than 40%，which bring fear to the patients，especially for those who cannot tolerate or refuse chemotherapy.Several studies indicated that the strategies of chemo-free ,such as the combination of immunotherapy with antiangiogenic therapy or with SBRT, were safe and well tolerated, without increasing adverse reactions. Both of them have a promising efficacy with a manageable toxicity profile in patients with resectable NSCLC. The investigators aim to assess the activity and safety of neoadjuvant SBRT and immunotherapy plus antiangiogenic therapy in patients with resectable NSCLC.
Interventions
RADIATIONSBRT
SBRT 8Gy\*3
DRUGImmunotherapy
Tislelizumab (immunotherapy) 200mg Q3W
Anlotinib 8mg D1-D14 Q3W
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.18 years or older 2. Eastern Cooperative Oncology Group performance status: 0 or 1 3. Clinical stage IB to IIIB (T3-4N2) Resectable NSCLC 4. Adequate cardiopulmonary and haematological function.
Exclusion criteria
1. Known EGFR-sensitising mutations and EML4-ALK fusions 2. Concomitant malignancy, history of another cancer within the past 3 years. 3. Current or previous use of immunosuppressive medication,active autoimmune disease, and interstitial lung disease or idiopathic pulmonary fibrosis on a screening radiographic scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response(pCR, rate) | At the time of surgery |
Secondary
| Measure | Time frame |
|---|---|
| Major pathologic response rate(MPR rate)，Disease-free survival（DFS, month），Event-free survival（EFS,month） | Major Pathologic Response (MPR, rate ):At the time of surgery Disease-Free Survival（DFS, month):From enrollment to disease recurrence or death from any cause Event-Free Survival（EFS,month）：From enrollment to the first pre-specified event |
Outcome results
None listed