Unresectable colorectal adenocarcinoma liver metastasis
Conditions
Interventions
Group 1:Oncorine+ mFOLFOX6 + bevacizumab
Group 2:mFOLFOX6 + bevacizumab
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. Histopathological diagnosis of colorectal adenocarcinoma; 3. The previous standard treatment failed; 4. The liver must have an injectable lesion that must comply with RECIST 1.1 measurable target lesions; 5. Liver lesions need to be judged by the surgeon to have poor prognosis of biological behavior; or surgical evaluation can be removed, but the patient refuses surgery, and the liver metastasis lesions need to meet the following requirements: The number of metastatic lesions should not exceed 5, and the sum of the longest diameters of the total metastatic lesions must be =100 mm; The longest diameter of the injected lesion must be 10mm to 80mm; 6. ECOG physical status score 0~1 points; 7. Expected survival time >=3 months; 8. Laboratory tests must meet the following criteria: white blood cell count >=3.0 x10^9/L, neutrophil absolute value >=1.5x10^9/L, platelet count >=100x10^9/L, hemoglobin >=90g/L; INR =50mL/min. 9. The date of treatment for the first time was >=14 days from the previous date of anti-tumor treatment, and it has recovered from previous anti-tumor treatment adverse reactions to baseline or level 1 [Common Evaluating Event of Common Adverse Events (CTCAE Version 5.0)] (except for hair loss and grade 2 anemia); 10. Voluntary signing of informed consent; 11. Female patients with fertility potential (including early menopause, menopause <2 years and non-surgical sterilization), male patients and male patients must agree to use effective contraceptives during the study period: surgical sterilization, oral contraceptives, palace The internal contraceptive, controlled libido or barrier contraception combined with spermicide; and continued contraception for 6 months after receiving the last treatment.
Exclusion criteria
Exclusion criteria: 1. Injectable lesions have received other local treatments such as ablation, intervention, and sea knife. 2. Previous treatment with oncolytic drugs or similar drugs (such as T-VEC); 3. Local lesions cannot meet the requirements of intratumoral injection volume or are not suitable for intratumoral injection; 4. Accompanied by malignant pleural effusion and ascites; 5. Receive antiviral therapy within 4 weeks before the first dose of the trial treatment, such as acyclovir, ganciclovir, valaciclovir, and adenosine; 6. It is known that patients with allergic to research drugs or their active ingredients, excipients or colorectal adenocarcinoma are allergic to oxaliplatin, levulinate, fluorouracil, bevacizumab and components; 7. Hepatitis B surface antigen (HBsAg) is positive and clinically determined to be active hepatitis B; 8. Hepatitis C virus (HCV) antibody, Treponema pallidum (TP) antibody, and human immunodeficiency virus (HIV) antibody positive; 9. In the case of other (including unknown primary) malignancies within 5 years prior to the first dose of the trial treatment, the following are excluded: Cure non-melanoma skin malignancy; Cervical carcinoma in situ; already cured stage I uterine cancer; Cure ductal carcinoma in situ or lobular carcinoma in situ, currently no systemic treatment; Localized prostate cancer that is currently considered to have been cured by radical surgery; Radical cure for solid tumors over 5 years without signs of recurrence; 10. Patients with any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, need Severe arrhythmia, liver, kidney or metabolic disease treated with drugs; 11. suffering from autoimmune diseases; 12. Patients with diseases (such as mental illness) or conditions (such as alcohol or drug abuse) may increase the risk of patients receiving test drug treatment or affect patients' compliance with test requirements, or may confuse the results of the study; 13. Within 14 days prior to receiving the study, the patient received any other test drug treatment or participated in another interventional clinical trial; 14. Pregnant or lactating women or women who are preparing to become pregnant or breastfeeding during the study; men or women who are unwilling to take effective contraception; 15. At baseline, there is evidence of central nervous system metastasis, except when the neurological symptoms return to CTCAE level 1 or below for at least 8 weeks after treatment (except for residual signs or symptoms associated with treatment), and systemic hormonal therapy has been discontinued ( Dosage >10 mg / day prednisone or other therapeutic hormones) greater than 2 weeks, and no disease progression in the head MRI examination within 28 days before dosing; 16. The investigator judges that the patient is not eligible for the other conditions of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;DCR;PFS; | — |
Countries
China
Contacts
Public ContactQing Xu
Shanghai Tenth People's Hospital
Outcome results
None listed