Lung cancer
Conditions
Interventions
single arm:Sintilimab for consolidation therapy
Sponsors
Fujian Province Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Pathology diagnosed with advanced lung squamous cell carcinoma without surgery or concurrent radiotherapy,meet any of the following criteria: (1) Systemic treatment for advanced or metastatic disease other than first-line GP regimen chemotherapy,EGFR and ALK gene test results were negative; (2) The first-line gemcitabine combined with cisplatin regimen after 4 cycles of chemotherapy was evaluated as SD or PR patients; 2. Aged >=18 years; 3. Expected survival time >=12 weeks; 4. There are at least 1 measurable or evaluable lesion according to the solid tumor efficacy evaluation standard version 1.1 (RECIST v1.1); 5. According to the US Eastern Oncology Group, the physical status score (ECOG PS score) 0-2; 6. The planned treatment plan includes the salibizumab; 7. Normal main organs function.
Exclusion criteria
Exclusion criteria: 1. Received a live attenuated vaccine within 4 weeks prior to enrollment or during the study period; 2. Active, known or suspected autoimmune diseases; 3. A history of primary immunodeficiency is known; 4. History of allogeneic organ transplantation and history of allogeneic hematopoietic stem cell transplantation; 5. Female patients who are pregnant or breastfeeding; 6. Untreated acute or chronic active hepatitis B or hepatitis C infection. In the case of patients receiving antiviral therapy, in the case of monitoring the number of copies of the virus, the doctor judges whether or not the enrollment is met according to the individual condition of the patient; 7. Uncontrolled concurrent diseases, including but not limited to: (1) HIV-infected (HIV-positive); (2) Severe infections that are active or have poor clinical control; (3) severe or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal diseases, uncontrolled hypertension) Evidence of greater than or equal to CTCAE grade 2 hypertension after drug treatment]; 8. Active bleeding or new thrombotic disease is taking a therapeutic amount of anticoagulant or bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;chemotherapy free interval; | — |
Countries
China
Contacts
Public ContactZhuang Wu
Fujian Province Cancer Hospital
Outcome results
None listed