Lung squamous cell carcinoma
Conditions
Interventions
Experimental group:Bortezomib combined with tirellizumab therapy
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged >= 18 years. 2. Histologically confirmed lung squamous cell carcinoma (requiring biopsy or bronchoscopy): (1) Diagnostic biopsy or bronchoscopy results must be diagnosed by a specialist pathologist. (2) Tumor biopsy samples can be formalin-fixed tissue blocks or 10 5µm tissue sections, which will be used for biomarker assessment (the pathologist must confirm that the samples are sufficient). These can be preserved samples, and new biopsies can be performed if necessary. (3) Locally advanced (IIIB stage) or metastatic (IV stage) disease (AJCC 8th). 3. At least one measurable tumor lesion (according to RECIST 1.1 criteria). 4. Patients who refused chemotherapy or were intolerant to chemotherapy during first-line treatment, or failed after first-line or multiple lines of treatment. 5. ECOG performance score 0-1. 6. Good organ function: (1) White blood cells >= 2000/mm^3 (2) Absolute neutrophil count (ANC) >= 1000/mm^3 (3) Platelet count >=100000/mm^3 (4) Hemoglobin >= 9g/dL (5) Creatinine = 12 weeks. 9. Patients voluntarily join this study, sign the informed consent form (ICF), have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients have received immunotherapy. 2. Patients have active, known or suspected autoimmune disease. Subjects with vitiligo, type 1 diabetes, hypothyroidism requiring only hormone replacement due to autoimmune thyroiditis, or conditions not expected to recur without external triggers are allowed to register. Systemic treatment with corticosteroids (more than 10mg prednisone equivalent daily) or other immunosuppressive drugs within 14 days of the first dose is excluded. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement steroids are allowed. 3. Patients with active concurrent malignancies, except for lung squamous cell carcinoma (excluding non-melanoma skin cancer, carcinoma in situ of the bladder, gastric cancer, breast cancer, colon cancer or cervical cancer/dysplasia), are excluded. 4. Patients with brain metastases are excluded from this study, and all patients should undergo brain imaging (enhanced MRI brain imaging or CT brain imaging) before enrollment. 5. Patients with active systemic infections requiring treatment, positive tests for hepatitis B surface antigen or hepatitis C RNA. 6. Patients with a history of interstitial lung disease. 7. Patients with peripheral neuropathy. 8. Known allergy to boron or mannitol. 9. Pregnant or lactating women. 10. Patients with hypertension that cannot be controlled within the normal range by antihypertensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg). 11. Patients with grade II or higher or poorly controlled cardiovascular disease. 12. Patients who have received other cancer treatments within 3 years before enrollment, except for basal cell carcinoma or cervical carcinoma in situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactSong Xu
Tianjin Medical University General Hospital
Outcome results
None listed