Extensive-stage small cell lung cancer
Conditions
Interventions
Observation group of extensive-stage small cell lung cancer:None
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-75 years old, gender not limited; 2.Patients with ES-SCLC confirmed by histology or pathology; 3.Has not received systemic anti-tumor treatment in the past; 4.ECOG PS 0-1 point; 5.Measurable lesions were evaluated according to RECIST 1.1; 6.The expected survival period is =3 months; 7.The main organ functions were normal (14 days before enrollment); 8.The subjects or their legal representatives have been informed of the nature of the study, understood the provisions in the protocol, can ensure compliance, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Those who are known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components; 2.Currently participating in and receiving other research treatments; 3.Previously received systemic treatment for ES-SCLC, including systemic chemotherapy, targeted therapy, immunotherapy, etc; 4.Patients with active pulmonary tuberculosis (TB) who are undergoing anti-tuberculosis treatment or have received anti-tuberculosis treatment within one year prior to screening; 5.Uncontrollable or symptomatic hypercalcemia (1.5mmol/L calcium ions or 12mg/dL calcium or corrected serum calcium ULN); 6.Clinically, there are uncontrolled active infections, including but not limited to acute pneumonia; 7.Uncontrollable major epileptic seizures or superior vena cava syndrome; 8.Have had or are currently concurrently suffering from other malignant tumors (except for non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast/cervical carcinoma in situ, superficial bladder cancer and other carcinoma in situ that have received radical treatment and have no evidence of disease recurrence); 9.Having a history of interstitial pneumonia, idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia, idiopathic pneumonia, evidence of active pneumonia found during chest CT scan screening, or other moderate to severe lung diseases that seriously affect lung function; 10.Have a known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 11.There are severe cardiovascular diseases, such as New York Heart Association (NYHA) grade 2 or above heart failure, unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident that occurred within 6 months before enrollment; 12.Within two years prior to the start of the study, the study had received systemic immunosuppressive drugs (i.e., corticosteroids or immunosuppressive drugs) for any active autoimmune disease; 13.Live virus vaccines were administered within four weeks before the start of the study; 14.Patients who have previously received allogeneic stem cell or parenchymal organ transplantation; 15.Pregnant or lactating women or women with the possibility of pregnancy who test positive for pregnancy before the first medication, patients who are fertile but unwilling to take contraceptive measures, or their sexual partners who are unwilling to take contraceptive measures; 16.Any other disease or condition of clinical significance that the researchers believe may affect protocol compliance (such as a history of mental illness or drug abuse), prevent the patient from benefiting from this clinical study, or affect the patient's signing of the informed consent form (such as drug abuse and drug abuse), or make the patient unsuitable to participate in this clinical study (including but not limited to: Abnormal laboratory results, clinically active diverticulitis, intra-abdominal abscess, intestinal obstruction, peritoneal metastatic cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Safety;Overall survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactCheng Yu
Yantai Yuhuangding Hospital
Outcome results
None listed