Lung cancer, colorectal cancer etal
Conditions
Interventions
Lung Cancer group:Novel Oncolytic Virus
Colorectal Cancer group:Novel Oncolytic Virus
Sponsors
Changde First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients with malignant solid tumors such as primary lung cancer and colorectal cancer diagnosed by histopathology; 3. Patients with positive circulating tumor cells (CTC) for more than 1 month after surgery or the last chemotherapy/radiotherapy; 4. Physical performance status score ECOG 0-2 points; 5. Laboratory tests: neutrophils>=1.5x10^9/L; platelets>=100x10^9/L; hemoglobin>=90g/L; normal liver and kidney function; 6. Can understand the situation of this study, patients and (or) legal representatives voluntarily agree to participate in this trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Have taken other drugs under clinical trials within 30 days before the first dose; 2. Those who have obvious traumatic injury within 2 weeks before the first use of the study drug; the subjects may receive other anti-tumor treatments during the study period and cannot continue the study; 3. The subject has active gastrointestinal diseases or other diseases that may lead to factors that significantly affect the absorption, distribution, metabolism or excretion of the drug; 4. Uncontrolled chronic systemic comorbidities (such as severe chronic lung, liver, kidney or heart disease); 5. According to the NYHA standard, patients with grade III-IV cardiac insufficiency; 6. Any disease that increases the risk of QTc prolongation or arrhythmia such as heart failure, hypokalemia, congenital long QT syndrome, etc.; 7. Any uncontrolled serious clinical research-related problems (such as substance abuse, uncontrolled psychotic states, uncontrolled complications including active infection, arterial thrombosis, and symptomatic pulmonary embolism); 8. There is a history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or evidence of interstitial lung disease during any clinical activity; 9. The subject is in the acute infection stage and needs drug treatment and antiviral treatment; 10. Subjects tested positive for HIV, HBV and HCV (HBV virus copy number >= 104 copies/mL, HCV virus copy number >= 103 copies/mL); 11. According to the judgment of the researcher, objective conditions (including the patient's psychological state, family relationship, social factors or geographical factors, etc.) make it impossible for the patient to complete the planned research or the subject has other factors that may cause the study to be terminated midway, and Concomitant treatment or abnormal laboratory tests; 12. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (such as poorly controlled hypertension, severe diabetes, thyroid disease, etc.; 13. Women who are pregnant or breastfeeding; 14. Autoimmune disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;overall survival;Quality of life;Safety;disease control rate;disease-free survival; | — |
Countries
China
Contacts
Public ContactWu Zhijun
Changde First People's Hospital
Outcome results
None listed