NSCLC-NED GC-NED
Conditions
Interventions
NSCLC-NED:surufatinib+standard therapy
GC-NED:surufatinib+standard therapy
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: Age =18 years old 2: Histologically confirmed locally advanced late or metastatic unresectable solid tumors (lung cancer, gastric cancer) with NED (neuroendocrinization, positive immunohistochemical expression of at least one neuroendocrine marker, CgA or Syn). 1) Lung cancer: Locally advanced or metastatic (stage IIIB, IIIC, or IV) non-squamous non-small cell lung cancer (NSCLC) that is histologically or cytologically confirmed to be inoperable and unable to receive radical concurrent chemoracial chemotherapy (according to the AJCC staging System Version 8) The NE component in tumor tissue was less than 50% in patients with no EGFR sensitive mutation, ALK, ROS1 gene fusion mutation driver negative. 2) Gastric cancer: advanced HER-2 negative gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) confirmed by histology or pathology, with NE component less than 30% in tumor tissue 3: ECOG score: 0-1 4: No systemic treatment has been received before, allowing early adjuvant/neoadjuvant therapyPatients with disease progression/recurrence during neoadjuvant/adjuvant therapy or within 6 months after the end of therapy were not enrolled 5: There was at least one CT measurable lesion, according to RECIST 1.1 criteria 6: Expect to survive for at least 3 months. 7: Major organ functions within 7 days prior to treatment shall meet the following criteria:(1) Hemoglobin (HB) =90 g/L(3) Platelet (PLT) =100×109/L. (2) neutrophil absolute value (ANC) =1.5×109/L; 8: Biochemical examination shall meet the following standards: (1) Total bilirubin (TBIL) =1.5 times the upper limit of normal value (ULN); (2) Alanine aminotransferase (ALT) and aspartate aminotransferase AST=2.5×ULN, and ALT and AST=5×ULN with liver metastasis; (3) Serum creatinine (Cr) =1.5×ULN or creatinine clearance (CCr)=60ml/min; 9: Patients of reproductive age (including female and male patients' female companions) must use effective birth control measures 10: Subjects voluntarily participated in the study and signed an informed consent form (ICF) 11: It is expected that the patient has good compliance and can follow up the efficacy and adverse reactions according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1: MSI-H/dMMR patients were confirmed by immunohistochemistry and/or PCR 2: Pregnant or lactating women 3: Patients who have participated in other clinical trials and have not terminated the trials 4: Patients with a definite tendency to gastrointestinal bleeding. Including the following cases: ? there are local active ulcer lesions, and stool occult blood 2+ or more (Patients with fecal occult blood 2+ were allowed to retest fecal occult blood, and patients who were judged by the researchers to have clear benefits could be enrolled) ? Patients with history of black stool and hematemesis within 3 months 5: Patients with any severe and/or uncontrolled medical conditions, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg) (2) Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmias (including QTc=480ms), and = grade 2 congestive heart failure (New York Heart Association (NYHA) grades) (3) Active or uncontrolled severe infection (=CTC AE grade 2 infection) (4) Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy (5) Renal failure requiring hemodialysis or peritoneal dialysis; (6) Urine protein =++ was indicated by two consecutive urine routine, and the 24-hour urine protein quantity was confirmed to be > 1.0 g ;(7) Mental illness, including epilepsy, dementia, severe depression, mania, etc; 6: Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to grouping (specifically in conjunction with clinical evaluation); 7: Accompanied by pleural effusion or ascites, causing respiratory syndrome (=CTC AE grade 2 dyspnea); 8: Patients who had received chemotherapy, radiation, or other experimental anticancer treatment (other than bisphosphonate) within 4 weeks prior to the initial administration of the study. Those who had previously received local radiotherapy were eligible if they met the following criteria: more than 4 weeks from the end of radiotherapy to the start of the study (more than 2 weeks for brain radiotherapy);In addition, the target lesions selected in this study were not in the radiotherapy area, or if the target lesions were in the radiotherapy area but progress was confirmed; 9: History of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc. 10: Patients whose imaging shows that the tumor has invaded important blood vessels or whose tumor is judged by the investigator to be highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study 11: Patients with any physical signs or history of bleeding, regardless of severity;Unhealed wounds, ulcers, or fractures were observed in patients with any bleeding or bleeding events =CTCAE grade 3 during the first 4 weeks of enrollment; 12: 6 months after the occurrence of arteriovenous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 13: Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; 14: Patients with severe allergic history or allergic constitution; 15: Pati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR;ORR;security; | — |
Countries
China
Contacts
Public ContactChen lingxiang
Jiangsu Cancer Hospital
Outcome results
None listed