Colon cancer
Conditions
Interventions
Experimental group:Conventional treatment +Oral adenine phosphate 20 mg three times a day after the start of treatment.
Control group:Conventional treatment
Sponsors
Xiamen University Affiliated Xiang'an Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily join this study and sign an informed consent form; 2.Age range: 18-85 years old; 3.Diagnosed with advanced colorectal cancer stage IV (AJCC TNM staging 8th edition.by pathology, systemic chemotherapy was performed; 4.According to the RECISST1.1 solid tumor efficacy evaluation criteria, there must be at least one measurable lesion; 5.ECOG score: 0-1 points; 6.Expected survival period exceeding 3 months; 7.No obvious contraindications for immunotherapy, targeted therapy, or chemotherapy; 8.The patient has no cognitive impairment or mental illness; 9.The patient is able to complete the survey form; 10.Patients can correctly understand and cooperate with the medication guidance of medical staff; 11.The patient did not receive any experimental drug treatment within 28 days prior to enrollment in the study; 12.The main organ function is normal, which meets the following criteria: (1)The blood routine test standards must meet the following criteria: no blood transfusion or blood products have been administered within the previous 14 days, and no correction has been made using G-CSF or other hematopoietic stimulating factors; Hemoglobin (HB)>= 90 g/L; Absolute neutrophil count (ANC)>= 1.5 × 10 ^ 9/L (1500/m3); Platelet count (PLT)>= 80 × 10 ^ 9/L; (2)Biochemical testing standards must comply with: total bilirubin (TBiL)= 50 ml/min (Cockcroft Gault formula); (3)The New York Heart Association cardiac function classification is 0-1, with no unstable angina or myocardial infarction, no symptomatic arrhythmias that cannot be controlled by drug therapy, and no clinically active other heart diseases within the 6 months prior to enrollment; Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF)>= lower limit of normal (50%).
Exclusion criteria
Exclusion criteria: 1.Serious active autoimmune disease exists; 2.Patients with congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA>104 copies/ml)or hepatitis C (hepatitis C antibody is positive, and HCR-RNA is higher than the detection limit of the analytical method); 3.Known to be allergic to the investigational drug or any of its excipients; 4.Uncontrolled hypertension; 5.Vaccination with live vaccine within 4 weeks prior to the first use of the investigational drug is allowed, and vaccination with inactivated virus vaccine for seasonal influenza is allowed. Attenuated vaccines are not included; 6.Pregnancy or lactation period; 7.Significant coronary artery disease in clinical practice or a history of myocardial infarction in the past 12 months, or a high risk of uncontrolled arrhythmia or uncontrolled cardiac dysfunction, chronic obstructive pulmonary disease requiring hospitalization three or more times in the past 12 months; 8.There is a psychological or medical condition that may hinder the patient from completing the study or granting their signature on the informed consent form; 9.Suspected or confirmed drug use, substance abuse, or alcoholism; 10.Conduct any experimental treatment within 30 days prior to entering the study; 11.Patients with any signs or medical history of bleeding, regardless of the severity; Patients who experience any bleeding or bleeding events within the first 4 weeks of grouping, with unhealed wounds, ulcers, or fractures; 12.Having a tendency to bleed or undergoing thrombolytic or anticoagulant therapy; Note: Under the premise that the international normalized ratio (INR)of the medical history time of thrombin disease is <= 1.5, the use of low-dose heparin (adult daily dose of 6000-12000 U.or low-dose aspirin (daily dose <= 100 mg)for preventive purposes is allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| White blood cell count;Cytokines and immune markers in plasma; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging assessment of changes in the patient's lesion after treatment (meets RECIST evaluation criteria);Safety and patient tolerance; | — |
Countries
China
Contacts
Public ContactKang Xinmei
Xiamen University Affiliated Xiang'an Hospital
Outcome results
None listed