Advanced lung cancer
Conditions
Interventions
Experimental group:chemotherapy combined with terriplizumab
Sponsors
Affiliated Hospital of Guilin Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.ECOG score 0-1. 2. Aged 18-65 years, male or non-pregnant female. 3. Patients with non-small cell lung cancer (stage IV) with histologically or pathologically confirmed driver gene negative, including but not limited to adenocarcinoma, squamous cell carcinoma, large cell carcinoma and other subtypes; Patients treated with standard chemotherapy in combination with Toripalimab for 4 cycles were assessed as having disease progression (primary progression or oligometastasis) or stable state (SD with a 10% or more increase in tumor volume). Oligometastases are defined as having 1 to 5 metastases and involving up to 3 organs (excluding the primary organ), involving all organs except diffuse serous metastases and allowing (meninges, pericardium, pleura, mesentery) and bone marrow involvement 4. Exclude metastasis as a secondary primary cancer. 5. Have at least one measurable target lesion as assessed by RECIST1.1. 6. Expected survival of at least 12 weeks; 7. Have adequate organ and bone marrow function, that is, hemoglobin (HGB)=90 g/L, white blood cells (WBC)=4×109 /L, platelets (PLT)=100×109 /L. Liver function: Total bilirubin TBIL <1.5 times upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)< 2.5 times upper limit of normal (ULN); If the patient has liver metastasis, ALT or AST< 5*ULN; If the patient has liver or bone metastases, alkaline phosphatase (AKP) < 5*ULN. Renal function: creatinine clearance is not less than 60ml/min. Prothrombin time (PT) International normalized ratio/prothrombin time (PTT) <1.5 times the upper limit of normal (ULN); 8. Sign informed consent, accept and comply with the research protocol, laboratory examination, follow-up, etc.; 9. Fertile female subjects and male subjects with fertile sexual partners must consent to the use of reliable contraceptive methods (e.g. condoms, regular use of birth control pills as prescribed by a doctor, etc.) for 6 months from screening until the last treatment.
Exclusion criteria
Exclusion criteria: 1. Present or present with other malignancies within 1.5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (cancer in situ), and T1 (tumor infiltrating basal membrane)]. 2. Patients who have previously received immunoregulatory point (CTLA-4, PD-1, PD-L1, etc.) inhibitors; 3. Subjects who are known to be allergic to either chemotherapy drug or triplizumab; 4. Previously received radiotherapy for metastatic lesions; 5.Have received systemic immunomodulators (including but not limited to interferon, interleukin 2) within 28 days; 6. Subjects have central nervous system metastasis; 7.28 days, there is a clear bleeding tendency or clinically significant bleeding symptoms, including but not limited to gastrointestinal bleeding, nasal bleeding (excluding epistaxis and retraction of aldicorrhea), and persistent bleeding disorders or coagulopathy; 8.Those who have cough up blood or hemoptysis (defined as coughing up or spitting up =1 teaspoon of blood or small blood clots or only coughing up blood without sputum) within 28 days, but blood in the sputum is not excluded; 9. Imaging shows that the tumor surrounds important blood vessels or invades the vascular area of important blood vessels, or the researchers judge that the tumor is highly likely to invade important blood vessels during treatment, causing the risk of massive bleeding; 10. A significant change in vertebral shape (vertebral height is compressed by =50%) or the vertebral body is unchanged, but the volume of dissolved bone is =50% and may cause serious bone adverse events; 11. Subject had any of the following severe acute comorbidities prior to enrollment: Unstable angina pectinis and/or congestive heart failure or vascular disease requiring hospitalization within 12 months (e.g., aortic aneurysm requiring surgical repair or peripheral venous thrombosis), or other cardiac impairment (e.g., poorly controlled arrhythmias, myocardial infarction, or ischemia) that the investigator determines may affect the safety evaluation of the investigational drug; ? The presence of esophageal and gastric varices, unhealed ulcers, unhealed wounds or fractures within 6 months; ? History of abdominal fistula, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding within 6 months; (4) Arterial thromboembolism events, venous thromboembolism of NCICTCAE grade 3 or above, transient ischemic attack (TIA), cerebral vascular accident (CVA) within 6 months, Hypertensive crisis or hypertensive encephalopathy; (5) Aggravated Chronic Obstructive Pulmonary Disease (COPD) or other respiratory disease requiring hospitalization within 28 days; ? Active lung infection and/or acute bacterial or fungal infection requiring intravenous antibiotic treatment within 28 days; ? Apparent jaundice caused by abnormal liver function within 7 days; Minor surgical procedures (including catheterization, excluding central venous catheterization by peripheral venipuncture) have been performed within 2 days; ? Currently have hypertension that cannot be well controlled by single antihypertensive medication (systolic blood pressure =160 mmHg diastolic blood pressure =100 mmHg); Or are being treated with a combination of two or more blood pressure medications. 12. Pregnant or lactating women who are in the fertile period and have not taken effective contraceptive measures. 13. Be HIV positive. 14. Complications that require pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-YEAR progression-free survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DOR;ORR;DCR; | — |
Countries
China
Contacts
Public ContactZhu Lin
Affiliated Hospital of Guilin Medical College
Outcome results
None listed