Non-small-lung cancer
Conditions
Interventions
Experimental group:Neoadjuvant chemotherapy combined with Immunotherapy followed by sequential radiotherapy+Pirfenidone capsules
Sponsors
The Second Affiliated Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old (including 18 and 75 years old); 2. Histologically confirmed, unresectable stage III non-small cell lung cancer (AJCC 9th) without systemic anti-tumor therapy; 3. ECOG score: 0-1 points; 4. Those who are expected to survive for more than 6 months; 5. Blood routine: ANC>=1.5×10^9/L, PLT>=100×10^9/L, Hb>=90g/L; WBC >=4.0×10^9/L and =40 mL/min; Coagulation function: APTT<=1.5×ULN, while INR or PT<=1.5×ULN (no anticoagulation); 6. Those who were able to eat solid food at the time of enrollment; 7. Subjects voluntarily join this study, sign written informed consent, and are able to comply with the visits and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1.Use of immuno-inhibitory drugs within 4 weeks of initial IBI308 treatment, not including nasal, inhaled or other routes of topical glucocorticoids or physiological doses of systemic glucocorticoids; 2.History of interstitial lung disease or autoimmune diseases; 3.History of lung resection surgery; 4.Pregnant women and patients with mental illness; 5.Other serious persistent diseases or organ system dysfunctions (including but not limited to persistent or active infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, active bleeding diathesis, and any condition that the investigator considers may jeopardize patient safety or interfere with the safety assessment of the trial medication). 6.Deemed unsuitable for participation by the researcher's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of level 2 and above radiation-induced lung injury;Progression-Free Surviva; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate;Treatment Cmpletion Rate; | — |
Countries
China
Contacts
Public ContactJie Peng
The Second Affiliated Hospital of Guizhou Medical University
Outcome results
None listed