Advanced squamous cell lung cancer
Conditions
Interventions
Experimental group:Sintilimab Injection 200mg Q6W maintenance therapy
Sponsors
General Hospital Of Eastern Theatre Command
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Age= 18 years old Histology/cytology confirmed advanced lung squamous cell carcinoma At least 1 measurable lesion (RECIST1.1) After 4 cycles of a platinum-containing regimen combined with sintilimab, no PD occurred ECOG PS 0-1 Expected survival= 3 months Allow stable brain metastases to enroll
Exclusion criteria
Exclusion criteria: 1) subjects with a prior history of other malignancies, except carcinoma in situ that achieved complete remission at least 5 years before screening and did not require or are expected to require additional treatment during the study; 2) subjects with known or suspected interstitial pneumonia; Other moderate to severe lung diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function. These include, for example, idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans; 3) Subjects with severe cardiovascular and cerebrovascular diseases, such as those who meet the NYHA criteria (grade III or higher), or myocardial infarction or cerebrovascular accident (cerebral ischemia, symptomatic cerebral infarction, etc.) that occurred within 3 months before the first dose, or unstable arrhythmia or unstable angina that occurred within 1 month before the first dose with coronary artery disease, or congestive heart failure outside the above criteria, or left ventricular ejection fraction of < 50% during the screening period, or superior vena cava syndrome with symptoms; 4) female subjects who are pregnant, lactating, or planning to become pregnant during the study; 5) History of live attenuated vaccination within 28 days before the first study or expected live attenuated vaccination during the study period; 6) Subjects with active hepatitis B (defined as positive HBsAg [HBsAg] test result during the screening phase with HBV-DNA test value = 2000 IU/ML) or hepatitis C (defined as positive hepatitis C virus surface antibody [HCsAb] test result and positive HVC-RNA during screening period); 7) Serious infection within 4 weeks before the first dose, including but not limited to infection complications requiring hospitalization or intravenous antibiotic treatment for =2 weeks, bacteremia, severe pneumonia, etc.; 8) Have clinically significant bleeding symptoms or obvious bleeding tendencies within 1 month before the screening, such as gastrointestinal bleeding, gastric ulcer bleeding, or vasculitis; 9) Uncontrollable moderate to large pleural effusion, abdominal effusion, or pericardial effusion that requires repeated drainage; 10) History of severe allergic reactions to other monoclonal antibodies; Have developed allergies or intolerances to infusions; History of severe allergies to pemetrexed, taxane, carboplatin, or their prophylactic medications. 11) The subject is known to have a history of psychotropic substance abuse, alcohol or drug abuse; 12) Any other medical (such as pulmonary, metabolic, endocrine or neurological diseases, congenital diseases, etc.), psychiatric illness, or social status that may interfere with the subject's rights, safety, health, or ability to sign informed consent, cooperate and participate in the study, or interfere with the evaluation of the study drug, the interpretation of the subject's safety, or the results of the investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Immune related adverse reactions;quality of life; | — |
Countries
China
Contacts
Public ContactHongbing Liu
General Hospital Of Eastern Theatre Command
Outcome results
None listed