squamous non-small cell lung cancer
Conditions
Interventions
experimental group:Camrelizumab: 200mg, iv, 30min, q3w, 24 months Paclitaxel For Injection (Albumin Bound): 260mg/ m2 iv d1
or Paclitaxel: 175mg/m2 iv d1
q3w, 4-6 cycles, Carboplatin: AUC=5-6, iVd1
or Cisplatin75mg/m2 iv d1
q3w, 4-6 cycles
Sponsors
Xingtai People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age:18-75 years old,male or female; 2. Subjects with histopathological diagnosis of squamous non-small cell lung cancer(IIIB-IV) who is unresectable and not fit for radical concurrent chemoradiotherapy 3. Subjects(IIIB-IIIC)who have not received prior systemic treatment 4. No prior systemic treatment for metastatic disease(NOTE: neoadjuvant and adjuvant therapy is allowed) 5. At least one measurable lesion (according to RECIST 1.1 standard tumor lesion CT scan long diameter>= 10mm); 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 7. Life expectancy greater than or equal to 3 months; 8. The main organs function well, and the inspection indicators meet the following requirements: 1) For results of blood routine test HB >= 90g/L; ANC >= 1.5 x 10^9/L; PLT >= 100 x 10^9/L; 2) For results of blood biochemical test ALB >= 30g/L ALT and AST = 50%. 10. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 11. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic brain metastases; 2. Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose); 3. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included); 4. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ); 5. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA >= 1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study ; 6. 6 months before study drug administration, the following occurred: myocardial infarction, severe / unstable angina pectoris, grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria, uncontrolled arrhythmias (including QTcF interval male> 450 ms, female> 470 ms ,The QTcF interval is calculated using Fridericia formula), symptomatic congestive heart failure, cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism); 7. Severe infections within 4 weeks before study drug administration (eg. Need intravenous drip antibiotics, antifungals or antivirals) or > 38.5 degrees C during screening visits or on the first scheduled day of dosing; 8. Imaging (CT or MRI) showed that the tumor invading the large vesselsor and the researchers judge that the tumor is likely to invade the important vessels and cause fatal hemorrhage 9. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 10. Less than 4 weeks from the last clinical trial; 11. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 12. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;Safty; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;DoR;OS; | — |
Countries
China
Contacts
Public ContactJun Guo
Xingtai People's Hospital
Outcome results
None listed