Malignant solid tumors
Conditions
Interventions
experimental group:New oncolytic virus: 1×10^7~9 PFU/Kg, intravenous injection, or intraperitoneal injection, or at the same time, once a week, for 8-12 weeks.
Sponsors
The First Affiliated Hospital of Guangxi University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 80 years , regardless of gender; 2. Patients with malignant solid tumors such as liver cancer and lung cancer were diagnosed by histopathology; 3. The patients with stage I-III after operation, and the circulating tumor cells were still positive more than 1 month after operation or the last chemotherapy / radiotherapy; 4. ECoG score was 0-2; 5. The expected survival time was more than 3 months; 6. Laboratory examination: neutrophils >= 1.5 x 10^9 / L; platelets >= 100 x 10^9 / L; hemoglobin >= 90g / L; the liver and kidney function were normal; 7.There was no second tumor in the past 5 years; 8.The patient and / or legal representative voluntarily agreed to participate in the trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Other drugs in clinical trials were taken within 30 days before the first administration; 2. The second tumor was diagnosed in recent 5 years; 3. Patients with obvious traumatic injury within 2 weeks before the first use of the study drug; subjects may receive other anti-tumor treatment during the study period, resulting in unable to continue the study; 4. Subjects with active gastrointestinal diseases or other diseases may lead to factors that significantly affect drug absorption, distribution, metabolism or excretion; 5. Uncontrollable chronic systemic comorbid diseases (such as severe chronic lung, liver, kidney or heart disease); 6. According to NYHA standard, patients with grade III-IV cardiac insufficiency; 7. QTc prolongation of baseline ECG (QTCF: male > 450 ms, female > 470 MS); 8. Any disease factor that increases the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia and congenital long QT syndrome; 9. Any uncontrollable serious clinical study related problems (e.g., substance abuse, uncontrolled psychiatric state, uncontrolled complications, including active infections, arterial thrombosis, and symptomatic pulmonary embolism); 10. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or evidence of interstitial lung disease during any period of clinical activity; 11. The subjects were in the stage of acute infection and needed drug treatment and antiviral treatment; 12. The subjects were positive for HIV, HBV and HCV (HBV copies >= 10^4 copies / ml, HCV copies >= 10^3 copies / ml); 13. According to the judgment of the researcher, the objective conditions (including the patient's psychological state, family relationship, social or geographical factors, etc.) make the patient unable to complete the planned study, or the subject has other factors that may lead to the termination of the study, and the abnormal combination treatment or laboratory examination; 14. According to the judgment of the researchers, there are some concomitant diseases (such as poorly controlled hypertension, severe diabetes, thyroid disease, etc.) that seriously endanger the safety of patients or affect the completion of this study; 15. Pregnant or lactating women;; 16. Autoimmune diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Disease-free survival (DFS);Overall survival time (OS);Quality of life (QOL); | — |
Countries
China
Contacts
Public ContactChunshan Li
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
Outcome results
None listed