Solid tumors
Conditions
Interventions
Experimental group:Azivudine
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Understand and voluntarily sign written informed consent; 2.Age 18-80 years old (including upper and lower limits); 3.Histologically or cytologically confirmed advanced solid tumors (including but not limited to primary liver cancer (HC-C), colorectal cancer, lung cancer, etc.), and primary liver cancer (HCC) can also be clinically or radiographically diagnosed (according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) of the National Health Commission), and the standard treatment has failed or cannot be tolerated; Before enrollment and during the middle stage of the study, the researchers could evaluate the tumor microenvironment by puncture of the tumor tissue according to the patient's condition, so as to guide the drug enrollment. Patients with colorectal cancer were enrolled in a non-mismatch repair-proficient (pMMR) or microsatellite stable (MSS) state. 4.ECOG Physical Condition (PS) score 0-1; 5.Child-Pugh score =12 weeks; 7.Presence of at least one measurable lesion at baseline (subject to RECIST 1.1); 8.The level of organ function and relevant laboratory indicators must meet the following requirements: Within 2 weeks prior to the first administration of A.NC, the following values can be maintained on routine blood tests without the treatment of macrophage colony-stimulating factor (G-CSF) up-whitening, platelet transfusion or thrombopoietin (TPO), red blood cell transfusion or erythropoietin: Absolute neutrophil count (ANC) >=1.5×10^9 /L; Platelet (PLT) count >=75×10^9 /L (if HCC is acceptable platelet count >=50×10^9 /L); Hemoglobin (HGB) >=90g/L; b. Blood biochemistry: serum total bilirubin (TBIL) <=1.5 times the upper limit of normal value (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3 times ULN (for HCC or other tumor liver metastasis, AST and ALT<=5 times ULN); Serum creatinine (SCr) <=1.5 times ULN; c. Coagulation function: International Standardized ratio (INR) or prothrombin time (PT) <=1.5 times ULN, activated partial thrombin time (APTT) <=1.5 times ULN; 9.Fertile female subjects must have a negative blood/urine pregnancy test result within 7 days prior to the first dosing of FNC, and female subjects must be willing to use adequate contraception during the trial and for at least 3 months after the last dosing of the study drug. Male subjects must agree to use birth control for at least 3 months from the start of the study until the last dose of FNC.
Exclusion criteria
Exclusion criteria: 1.Previous antitumor and surgical treatment history met any of the following criteria: Within 2 weeks prior to the first administration of FNC, patients were in the treatment period of other clinical studies of intervention; has undergone major surgery or has not fully recovered from any prior invasive operations within 4 weeks prior to first administration of FNC; 2.Toxicity from previous antitumor therapy did not recover (NCI-CTCAE v5.0, > Grade 1), except for alopecia and pigmentation, previous chemotherapy-related neurotoxicity (=150/90mmHg); severe uncontrolled arrhythmias requiring medical treatment; Electrocardiogram (ECG) examination, QTc interval >470 ms; Left ventricular ejection fraction =200ml) within 3 months; 9.The presence of any uncontrolled active infection within 2 weeks prior to the first dose of FNC that prevented the subject from receiving the study drug; 10.Other serious systemic diseases, including but not limited to uncontrolled diabetes, kidney diseases requiring dialysis, acute pancreatitis, etc.; 11.A clear history of neurological or psychiatric disorders, including epilepsy or dementia; 12.Pregnant or lactating women; 13.Because of poor compliance, the researcher judged that it was not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicity (DLT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (AE);Objective response rate (ORR);Disease control rate (DCR);Progression-free survival (PFS);Duration of response (DOR);Overall survival (OS);Tumor progression time (TTP);Relationship between MDSCs and efficacy; | — |
Countries
China
Contacts
Public ContactXuemei Zhu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed